Cataract Surgery

In progress

ArcScan: To assess if using a high resolution immersion ultrasound measurement improves intraocular lens power calculation

Immersion ultrasound can be used to calculate the needed power of an intraocular lens (IOL) to achieve the aimed post-operative refraction. Although IOL power calculation improved within the last decades, refractive surprises occur. The estimation of the postoperative IOL position and therefore the estimated anterior chamber depth (ACD) is presently the main source of error in IOL power calculation. The ArcScan Insight 100 scanner is an immersion ultrasound device to create high resolution B-scans (=images) of the anterior segment of the eye. Aim of this study is therefore to assess if the additional use of high resolution immersion ultrasound measurements improve the refractive outcome after cataract surgery.

In progress

Computer-based tutorial as supportive means to enhance quality and efficiency of the informed consent process for cataract surgery in Turkish or Serbian speaking patients

Informing the patient and obtaining informed consent is one of the major duties physicians have to perform before beginning a medical treatment. However, patients often experience the informed consent taking as not satisfying. A novel concept introduced several years ago is to use a multimedia tool including a so-called traffic light system. The patient sees and hears information concerning cataract surgery on a touch screen and after each short chapter a traffic light is shown on the touch screen. At this point the patient has to decide, whether everything is clear and he wants to continue (green light), if he has further questions for the ophthalmologist (yellow light), or if he wants to repeat the chapter (red light). The patient’s feedback for each chapter is then printed and guides the ophthalmologist during the face to face discussion. This approach is called “CatInfo tool”. Aim of this study is to develop and evaluate a new version of the CatInfo tool for patients fluent in Serbian or Turkish.

In progress

Effect of Cataract extraction on retinal sensitivity measurements using microperimetry (Micro Perimeter 3) - Pilotstudy

Microperimetry is a method to assess retinal sensitivity in the central visual field. This technique combines perimetry with fundus photography to correlate retinal sensitivity with morphology, so called “fundus-related perimetry”. The measurements can be performed without pupil dilation in a non-contact fashion. Hence, this technique can be easily performed in patients suffering from different eye diseases to evaluate central visual function. However, clear optical media is necessary to obtain reliable results. Aim of this study is to evaluate the effect of cataract extraction on retinal sensitivity measurements.

In progress

Myopred: Influence of posterior vitreous detachment on retinal detachment after lens surgery in myopic eyes

In most cases the functional and clinical outcomes of phacoemulsification with implantation of posterior chamber lenses are excellent and high patient and clinician satisfaction has been reported. However, there is a risk of developing complications such as pseudophakic retinal detachment (PRD) after surgery. Especially, myopic patients have an increased risk of PRD compared with the general population. The aim of the study is to document the pre-operative presence and/or post-operative development of PVD and to assess its influence on the incidence of PRD in myopic patients in a time period of three and five years after lens surgery.

In progress

IFIS II: Effect of the selective alpha 1A receptor antagonist tamsulosin on the thickness of the iris dilator muscle

IFIS is a syndrome usually caused by systemic alpha 1A blockers used to treat benign prostatic hyperplasia. It is known that alpha 1A receptor antagonists are located on the iris dilator smooth muscle. Aim of the study is to assess the effect of selective alpha 1A blockers on the thickness of the iris dilator muscle assessed with OCT and evaluate if there are differences between patients with selective alpha 1A receptor blockers and a control group with no history of an intake of tamsulosin.

In progress

Effekt of air-tamponade on intraretinal cystoid changes after 23G ppV with membrane peeling

Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT). Different study groups showed that even intraoperative use of SD-OCT is possible. The aim of the study is to examine the effect of air tamponade during 23G-pars plana vitrectomy with membrane peeling on intraretinal cystoid changes due to ERM.

In progress

Low Asti: Assessing the astigmatism reducing effect with toric IOLs in eyes with low astigmatism

With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate amounts of astigmatism. However, there is still uncertainty, if low astigmatism should be corrected since in eyes with low corneal astigmatism the accuracy of measuring the astigmatism meridian is relatively low and different corneal measurement techniques are not always comparable. Hence, we want to assess, if toric IOLs are useful in patients with low amounts of corneal astigmatism and to quantify the sources of error in toric IOL power calculation.

In progress

Negative Dysphotopsia: Defining and quantifying negative dysphotopsia and characterization and causative factors of negative dysphotopsia

Negative dysphotopsia describes an optical phenomenon occurring after uneventful, modern cataract surgery. Its hallmark is a sickle shaped shadow usually in the far peripheral, temporal visual field recognized by the patient. Purpose of the study is to identify causative factors for negative dysphotopsia. Further, this exploratory study will try to find associations between patient complaints of negative dysphotopsia, ocular biometry and psychophysical test results.

In progress

Neuromaster: Pain perception and discomfort of second eye cataract surgery in comparison with the first eye in correlation with perioperative stress

Phacoemulsification cataract surgery in topical anaesthesia has become the anaesthetic method of choice. Although this procedure has proven to be relatively painless, safe and effective, patients report increased pain or discomfort during surgery of the second eye. The purpose of our study is to find a correlation between agitation (stress) indicating parameters and the pain perception during second eye cataract surgery, compared to first eye cataract surgery.

In progress

OCT Catgrading: Cataract quantification using swept source-based optical coherence tomography: a pilot study

Cataract quantification can be a very difficult venture. On the one hand the patients are affected differently by the different types of cataract. On the other hand, the tools available to the ophthalmologist to assess cataract are subjective and so the assessment of cataract is examiner dependent. Aim of this study is the quantification of different cataract types using swept source OCT technology and comparison with other imaging methods, contrast vision assessment and visual acuity testing.

In progress

Evaluation of reading quality in three different patient groups (Extended Range Of Vision vs minimonovision vs single focus distance vision)

Reading is a complex process. It requires a good retinal image. Reading speed slows down when the understanding is difficult, which is why reading one’s mother tongue generally is faster than reading a foreign language. Reading skill is therefore influenced by visuo-motor and cognitive (i.e. linguistic, personality, learning, ageing) factors. The aim of the study is to assess the influence of different ophthalmic conditions after cataract surgery (extended range of vision IOL (EROV) with micromonovision, minimonovision with standard IOL and single focus distance vision with standard IOL) on reading quality. Assessed with using a high-speed eyetracking device. This study is done in cooperation with the university of Crete.

In progress

Two center trial with medical university Graz: Influence of combined vitrectomy plus cataract surgery on postoperative intraocular lens position: a prospective bilateral comparison

Even with modern measurements techniques, such as optical biometry, and using the latest generation of IOL power calculation formulae, there is a relevant unpredictability of the post-operative manifest refractive outcome. However, most studies are focusing on cataract surgery and there is little literature concerning the prediction of the post-operative IOL position in combined cataract surgery with vitrectomy. Combination of cataract operation with vitrectomy for vitreomacular diseases has the advantage of better visualization of the posterior pole during the operation in eyes with a (sub)clinical cataract. Aim of this study is to assess the influence of combined vitrectomy and cataract surgery on the post-operative IOL position in comparison to cataract surgery without additional surgery.

In progress

Oculentis (Multifokal vs Monofokal): Comparison between bilateral low-add multifocal intraocular lenses and monofocal intraocular lenses: a randomised trial

Although bilateral monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of patient satisfaction in distance vision, spectacle dependence for intermediate vision, reading and other near vision tasks is the usual result. One option to enhace intermediate vision and to leave patients with good contrast sensitivity is the use of low-add multifocal IOLs. One example of these low-add multifocal IOLs is the LENTIS Comfort MF15 with a near add of 1.50D. Its single transition zone works to deliver patients the same kind of distance vision as a monfocal IOL with the addition of enhanced intermediate vision. This should result in better unaided distance vision and therefore higher patient satisfaction after cataract surgery. The rationale of this study is to compare the clinical performance of low-add multifocal IOLs with monofocal IOLs concerning visual function and spectacle independence for distance vision.

In Progress

Trifocal: Comparison of visual performance of 2 diffractive trifocal intraocular lenses: a randomised controlled trial

Although bilateral monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of patient satisfaction in distance vision, spectacle dependence for reading and other near vision tasks is the usual result. The options commonly used to achieve spectacle independence are multifocal intraocular lenses (IOLs). Multifocal IOLs either use a refractive or diffractive design or a combination of both or segmented asymmetric optics. The principal of the refractive design is based on changing the route of light rays by thickness, curvature and optical density of the lens. The purpose of the study is to compare two commercially available bilaterally implanted diffractive trifocal lenses (one eye = Zeiss AT Lisa tri 839 MP IOL; contralateral eye = Rayner trifocal) with cataract surgery concerning visual function (specifically uncorrected near visual acuity) and spectacle independence.

In Progress

Artisan IOL: Visual acuity outcome after implantation of an iris-fixated and scleral fixated IOL in eyes with no capsule support

In uncomplicated cataract surgery the intraocular lens (IOL) is implanted in the capsular bag. However, in those cases where there is no capsule bag support, the IOL has to be placed at an alternative position. One common position is to fixate the IOL at the iris (retropupillary) using an iris-claw-IOL. This technique was shown to be safe and efficient. This study evaluates the outcomes of patients with those IOLs.

In Progress

LUCIA II: Prospective clinical trial to compare the postoperative horizontal position stability of the CT LUCIA 611P and the CT ASPHINA 409 MP

In the past few years, refinements in surgical technique and modifications in intra ocular lens (IOL) design and material have led to a decreased incidence of posterior capsule opacification (PCO) and lens tilting or decentration. Moreover, much effort has gone into developing advanced phaco machines and foldable IOLs for cataract surgery. This improvement has several advantages, including rapid visual restoration with minimum postoperative inflammation, less iatrogenic corneal damage, and lower surgically induced corneal astigmatism.

Two types of lens designs are predominantly used during cataract surgery (open loop design and plate haptic). Aim of this study is to compare two CE- marked intraocular lenses with different designs (CT ASPHINA 409MP versus CT Lucia 611P) concerning anterior chamber depth as the main outcome and secondly their axial stability in the bag as well as centration, tilt, visual acuity and refraction postoperatively.

In progress

IFIS I: Predicting the severity of IFIS before surgery

Cataract surgery is one of the most frequently performed surgeries worldwide and complications are rare. However, there are factors that increase the risk of complications, such the intra-operative floppy iris syndrome (IFIS). IFIS is a syndrome usually caused by systemic alpha 1A blockers used to treat benign prostatic hyperplasia. The objective of this study is to assess the effect of selective alpha 1A blockers on the pupil size before and after the instilliation of tropicamide 0.5% and phenylephrine 10% to evaluate if there are differences between patients with selective alpha 1A receptor blockers and a control group with no history of an intake of alpha 1A receptor blockers.

In progress

Rhexis Protection Shield: Protecting the corneal endothelium during cataract surgery using the anterior capsule bag: a prospective randomised double-masked study

One of the main complications during phacoemulsification, is damaging the endothelium due to contact with swirling lens fragments of nuclear fragments, resulting in corneal damage, inflammation of the endothelium and corneal edema.

The intention of this study is to assess if the use of a protection shield consisting of the rhexis flap leads to a significantly reduced loss of endothelial cells compared to standard cataract surgery in a prospective randomised fashion.

In progress

TILT: Tilt of the intraocular lens in patients undergoing combined phacoemulsification and vitrectomy with airtamponade

Due to the possibility of vitrectomy induced cataract, in many ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and vitrectomy in case of existing cataract. The aim of the study is to document tilt of the intraocular lens in combined phacoemulsification and vitrectomy by photography of purkinjereflexes. During vitrectomy tamonade with air or saline are regarded as equal in substituting the removed vitreous.

In progress

Swept Source OCT biometry: Feasibility study to evaluate the applicability of the “Cataract and Refractive Imaging Platform” for measurements in different ocular conditions.

The Heidelberg Engineering “Cataract and refractive Imaging Platform” is a non-CE marked Swept-Source OCT ophthalmological imaging and measurement device. Analyzed metrics include anterior and posterior corneal topography, corneal pachymetry, anterior chamber depth and –angle, lens thickness, axial length, pupil diameter and corneal diameter. This study evaluates the feasibility of the Cataract and refractive Imaging Platform’s technology in terms of acquiring OCT images of eyes with certain ocular conditions (normal eyes, corneal irregularities, dense cataract, pseudophakia, macula pathologies, long eyes) that are appropriate for later metric assessment. Secondary, repeatability and reproducibility of results will be looked at.

In progress

Toric IOL: Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens (Model YST0.00)

TModern toric IOLs typically show a mean absolute rotation of 3° to 5° , which would result in a loss of about 10% to 15% of the astigmatism reducing effect of the toric IOL. Rotational stability of a toric IOL depends on the in teraction between the toric IOL and the posterior capsule, whereas misalignment of the toric IOL depends on several factors additionally to rotational stability. Intraoperatively, misalignment may happen due to cyclotorsion of the eye in the lying position or due to peribulbar anaesthesia, and due to imprecision of the surgeon when positioning of the IOL relative to the intended meridian.

The primary objective of this study is to evaluate rotational stability of the investigational device implanted after cataract surgery. The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

Other Studies

In progress

Eplerenon: A randomized, double-masked, placebo controlled study of the beneficial effects of eplerenone on central serous chorioretinopathy

Central serous chorioretinopathy (CSC) is supposedly the fourth most common non-surgical retinopathy after age-related macular degeneration, diabetic retinopathy and branch retinal vein occlusion. Aim of this study is to compare the treatment effects of eplerenone, an aldosterone antagonist versus placebo in patients with acute or chronic CSC with an untreated observational period of at least 2 months. If there is no sign of clinical improvement within the first 16 weeks after the onset of symptoms, patients will be offered half-fluence PDT.

In progress

Caffeine and lens: Pharmacokinetics of caffeine in the lens after oral intake: a pilot study

Caffeine is a world wide consumed dietary constituent. A new interest for caffeine in ophthalmology emerged with the observation that caffeine inhibits cataractogenesis. The aim of the study is to investigate if oral caffeine intake leads to caffeine accumulation in human lens and lens epithelial cells.

In progress

Intra-OP OCT: Using an intra-operative optical coherence tomography device for predicting the intraocular lens position

Since the introduction of optical biometry (IOLMaster, Carl Zeiss Meditec AG, Jena, Germany) as a reliable non-contact measurement of the axial eye length the influence of the error of axial length measurement on the refractive error decreased from over 50% (when measured with applanation ultrasound) to 36%. These results show that the estimation of the post-operative intra-ocular lens (IOL) position and therefore the estimated anterior chamber depth (ACD) is presently the main source of error (35% 3 to 42% 2) in IOL power calculation and therefore for the refractive outcome of the patients after cataract surgery. The aim of this study is to observe whether the number of successful intra-operative scans of the lens capsule position after cataract removal can be increased to a minimum of 98% and whether the refractive outcome could be improved by using both pre- and intra-operative measurements for IOL power calculations.

In progress

ILM Flap: Visual acuity and retinal morphology one year after ILM-flap transposition for macular hole repair

Vitrectomy with peeling of the internal limiting membrane has developed to be the gold-standard in treatment of macular holes. Recently a new technique has come up, vitrectomy with ILM-flap transposition, offering better postoperative success rates. The aim of the study is to assess one year follow-up data from patients having undergone 23G pars plana vitrectomy with ILM flap transposition at the Hanusch hospital.

In progress

FTIR: Fourier Transformed Infrared Microspectroscopy of epiretinal membranes and internal limiting membranes

Fourier Transformed Infrared Microspectroscopy (FTIR) analyses probes by absorption of infrared light due to molecules and their states of vibration in the probe. Spectra of absorption offer information about molecular components of the probe. Purpose of the present study is to analyse components of ERM and ILM, giving hints for the origin of cells producing ERM. In contrast to electron microscopy, FTIR does not need any chemical fixation of the membranes and therefore structure of components of ERM and ILM are not changed by fixation.

In progress

Conjunctivitis: A Phase 3, multi-center, randomized, double-masked study to evaluate the clinical efficacy and safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension compared to PVP-Iodine and Placebo in the treatment of adenoviral and bacterial Conjunctivitis

The clinical presentation of conjunctivitis is often nonspecific and differential diagnosis of different types of conjunctivitis can be challenging. Diagnostic testing to differentiate the underlying cause of infection is rarely performed in a clinical setting; misdiagnosis can occur in up to 50% of cases, which often results in improper antibiotic treatment. Currently there is no approved medication for the treatment of adenoviral conjunctivitis. An unmet need therefore exists for a safe and efficacious treatment that addresses infectious conjunctivitis (adenoviral and bacterial). By combining PVP-I, a potent topical antiseptic with proven antiviral and antibacterial activity, with dexamethasone, a topical steroid, SHP640 should enable the treatment of both the infectious and inflammatory components of adenoviral and bacterial conjunctivitis even when the cause of infection is unclear. The primary objective of this study is to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and watery conjunctival discharge) compared with placebo in the treatment of subjects with adenoviral and bacterial conjunctivitis in the study eye at Visit 3 (Day 6).

In progress

Formycon: Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to lucentis in patients with neovascular age-related macular degeneration (Columbus-AMD)

Age-related macular degeneration (AMD) is a progressive degenerative disease of the foveal center point (macula). There are two types of AMD: dry (atrophic) and wet (neovascular or exudative). Recent scientific reports suggest that the vascular endothelial growth factor (VEGF) plays a crucial role in the pathophysiology of the wet form of AMD. Hence, one therapeutic approach is the treatment with Ranibizumab (Lucentis®), a VEGF inhibitor. Ranibizumab (FYB201) is a biosimilar of this drug and should work in a similar manner. The objective of this study is therefore to evaluate and compare safety and therapeutic success of the biosimilar Ranibizumab (FYB201) in comparison to the reference product Lucentis in patients with wet AMD.

In progress

Keratoconus: Using a keratoconus registry data base and evaluation of the German version of a validated keratoconus questionnaire (KORQ)

Keratoconus is a corneal disorder where the paracentral (and central) cornea undergoes progressive thinning and steepening causing irregular astigmatism. Treatment of keratoconus depends on the stage of the disease: in a stable keratoconus contact lenses could be sufficient, whereas in the case of progression cross linking is recommended and in severe cases corneal surgery is required. However, knowledge concerning long-term progression/ stability after treatment is lacking and many studies involved only small samples. To observe a large number of patients a worldwide keratoconus registry is necessary, and one of this registries is the Fight Corneal Blindness registry. Due to the fact that there is no specific questionnaire available in German, we would like to translate and validate the Keratoconus Outcomes Research Questionnaire (KORQ).

In progress

PLSG: Partial least squares regression modelling for glaucoma detection using retinal nerve fiber layer, ganglion cell layer and visual field data

Glaucoma is a term describing a group of ocular disorders with multifactorial aetiology and chronic optic neuropathy. Whereas in former days mainly intraocular pressure and visual field testing were available for glaucoma detection and progression analysis, different imaging techniques have improved the early glaucoma detection significantly. As in our glaucoma clinic all patients are routinely having visual field test and a RNFL Scan, this study only requires an additional RGCL scan using the same OCT device (Spectralis OCT) and a RNFL and RGCL scan using a different OCT device (Cirrus, Carl Zeiss Meditec AG) and additional microperimetry (MP3, Nidek, Japan). Aim of this study is to develop a partial least squares regression model incorporating RNFL and RGCL measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma.

In Progress

Glaukom MP3: Follow up measurements for partial least squares regression modelling for glaucoma detection using retinal nerve fiber layer, ganglion cell layer and visual field data

This is a follow-up to the “Partial least squares regression modelling fo glaucoma detection using retinal nerve fiber layer, ganglion cell layer, and visual field data” study. Aim of this study is to reevaluate patients who already undergone visual field examinations with a conventional and microperimertry as well as OCT measurements in order to develop a partial least squares regression model incorporating RNFL and RGCL measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma.

In Progress

Reading performance: Reading analysis in ophthalmological patients - Pilotstudy

Reading is a complex function. It requires a proper retinal image that is received by the brain. Reading speed slows down when letters are blurred, or do not have enough contrast or luminance or when binocular fusion is hampered or due to scotoma. Hence, it is obvious that reading ability is reduced in patients with various ocular diseases. The present study is designed to investigate the reading parameters and fixation behavior in patients with different ocular diseases (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal membrane) and healthy subjects. In addition, fixation analysis and retinal sensitivity measurements will be done with the microperimeter (MP3, Nidek, Japan) in each subject.

Completed Studies

Completed

Rotational stability of the Toric Tecnis one-piece IOL: a pilot study

The rotational stability of a new Toric Tecnis one-piece IOL with C-haptic is in the focus of this pilot study. It is an aspheric acrylic toric IOL with a sharp optic edge design to inhibit PCO formation. The haptic design is supposed to ensure rotational stability. For astigmatism correction, an IOL rotation of 3° would result in a loss of astigmatism correction of 10% and rotation of 10° in a loss of one third of the correction.

Completed

Rotational stability of the single-piece acrylic IDEA 613 XC® IOL: a pilot study

In this study the rotational stability of a new hydrophilic acrylic aspheric single-piece IOL with an open-loop haptic should be assessed. It is a standard monofocal IOL with markings as found in toric IOLs. The IOL has a sharp optic edge design to inhibit PCO formation. The haptic design is supposed to ensure rotational stability.

Completed

Corneal changes induced by limbal relaxing incision and opposite clear corneal incision

Besides implanting a toric IOL for reducing astigmatism, various other surgical techniques can be applied, for example setting an opposite clear corneal incision (OCCI) or a limbal relaxing incision (LRI). These methods of astigmatism correction are commonly used, but the influence on corneal morphology and function is still in question. In this study viscoelastic properties of cornea and their influence on topographic changes after different astigmatism-reducing incisional techniques will be assessed using dual rotating Scheimpflug imaging with a Placido disc and an Ocular Response Analyzer.

Completed

Comparison of toric IOL implantation and opposite clear corneal incision during cataract surgery to correct corneal astigmatism

There are different methods to correct corneal astigmatism during cataract surgery. One method is to implant a toric IOL, another method is to set an opposite clear corneal incision (OCCI). Purpose of this study is to compare the astigmatism reducing effect of a toric IOL with that of opposite clear corneal incision surgery combined with a spherical standard IOL. First findings show that OCCI as well as toric IOL implantation effectively correct low preoperative corneal astigmatism.

Completed

Evaluation of an intra-operative tracking system for toric IOL positioning

Toric IOLs that correct corneal astigmatism are introduced more widely to cataract surgery. Key for success is precise alignment of the cylindrical axis of the IOL with the astigmatic axis of the cornea. In this study an intra-operative marking method will be analysed to show if intra-operative marking results in a higher precision of the postoperative IOL alignment.

Completed

Impact of incision size and architecture on wound stability and astigmatism in cataract surgery: an exploratory study

This exploratory study centres on examining wound architecture of clear corneal incisions using an intra-operative continuous OCT. One aim of this study is to quantify the influence of intra-operative wound architecture on resistance to deformation of the wound and surgically induced astigmatism in micro incision cataract surgery and small incision cataract surgery. Furthermore effect of a hinged incision with a pre-cut will be assessed in a second part.

Completed

Methods to manage intra-operative floppy-iris syndrome and poor pupil dilation in cataract surgery: a randomised study

Intra-operative floppy-iris syndrome (IFIS) and poor pupil dilation are two factors that increase the risk of complications in cataract surgery. In this study different methods to manage IFIS and poor pupil dilation will be investigated. The use of a viscoadaptive OVD will be compared to the use of a dilating device such as the Malyugin Ring or iris hooks. Purpose is to observe which strategy results in the lowest aqueous flare post-operatively.

Completed

Efficacy and safety assessment of intracameral T2380 (fixed combination of lidocaine, phenylephrine and tropicamide) for mydriasis and anaesthesia in phacoemulsification cataract surgery

Usually, thirty minutes before a cataract surgery commences, a mydriaticum as well as a local anaesthetic are repeatedly dropped into the eye to provide the patient reversible loss of pain and to allow the surgeon to extract the crystalline lens and to inject the IOL. In this study a newly developed dissolution which is a fixed combination of lidocaine, phenylephrine and tropicamide will be injected intracameral and efficacy and agreeability will be assessed.

Completed

Safety and efficacy of a novel hydrophobic acrylic IOL – iPure: a randomised study

The sharp posterior optic edge design, the 360° square edge and the higher adhesiveness of the hydrophobic acrylic raw material to the capsular bag of the new IOL called iPure seem to be able to minimize posterior capsule opacification (PCO). However, a major drawback of hydrophobic materials were glistenings. A recently developed acrylic IOL seems to show almost no glistening. Observing the efficacy of this new IOL regarding rotational stability, glistening, PCO, axial stability in the bag centration and tilt are the main aim of this study.

Completed

Reducing the use of reading spectacles in pseudophakic patients - "Motivation Study"

In general, pseudophakic patients are unable to accommodate. But some cases, patients who have undergone cataract surgery manage to achieve good distance and near vision and do not need glasses for either distance. This is attained through a large depth of focus of the eye or pseudoaccommodation, and other factors. Aim of this study is to assess whether motivation of patients to attempt to do near work without glasses and ‘exercise’ their near vision, results in less spectacle dependency in patients, who have undergone bilateral cataract surgery within the last year.

Completed

Impact of rotating lens cortex fragments on the endothelial cell outcome after phacoemulsification

One of the main complications during phacoemulsification in cataract surgery is the damaging of the endothelium due to contact or collision of lens fragments of the nucleus following turbulent flow of irrigating solution. This can result in corneal damage, inflammation of the endothelium and corneal oedema. In this study an intra-operative OCT will be used to observe the impact of rotating fragments of the crystalline lens on the endothelial cells of the cornea.

Completed

Predictability of the IOL position using an intra-operative OCT

Accurate IOL power calculation is essential for a good refractive outcome in cataract surgery. Estimation of the post-operative IOL position and therefore the estimated anterior chamber depth (ACD) is nowadays the main source of error in IOL power calculation. Proper measurement of the position and the size of the crystalline lens as well as of the lens capsule after removing the crystalline lens is necessary to improve IOL power calculation. Aim of this study is to evaluate the correlation of these measurements using an intra-operative OCT to the post-operative ACD as well as the refractive outcome.

Completed

Capsule bag performance of a novel single-piece acrylic IOL - HOYA AF-1 NY-60

In this study the capsule performance and stability of a new single-piece microincisional hydrophobic acrylic IOL has been assessed in subgroups of normal, short and long eyes. Results: The single-piece microincisional hydrophobic acrylic IOL showed good axial stability and only little tilt and decentration in the first 3 months postoperatively.

Completed

Aqueous flare of a hydrophobic acrylic single-piece open-loop IOL with modified material surface properties

Aim of this study is to assess the efficacy of the newly modified surface of the “Polylens” IOL compared to the same IOL without a modified surface concerning flare and cell intensity in the anterior chamber as well as cellular components on the IOL surface and lens epithelial out-growth from the rhexis after cataract surgery in eyes of patients with diabetes mellitus and pseudoexfoliation syndrome which typically have a higher incidence of post-operative intra-ocular inflammation.

Completed

Validation of the German version of a 9-item questionnaire to evaluate patients' satisfaction undergoing cataract surgery

Catquest-9SF is a short form of the longer Swedish CatQuest, a questionnaire to measure the patients’ quality of life and their satisfaction level for cataract surgery. Aim of this study is to validate the German version of the Catquest-9SF. The questionnaire includes three parts, the first part asks if there are any difficulties for the patient in every day live because of vision, in the second part the patient has to answer how satisfied or dissatisfied he is with his vision and the third part asks about difficulties when performing activities, such as reading, doing handwork, or recognising people’s faces. With this questionnaire it will be possible to respond better to the patients’ needs.

Completed

Computer-based tutorial as supportive means to enhance quality and efficiency of the informed consent process for cataract surgery

Studies have shown that patients often cannot remember the most important and essential parts of the communication with their clinician. Consequently, the level of information provided to the patient by the practitioner for purposes of the informed consent is often inadequate, particularly when the patient has to undergo a surgical intervention. For this reason a computer-based tutorial was developed. Aim of this study was to compare, if patients who are informed using the novel computer-based CatInfo tool and the face-to-face interview are better informed than patients that are informed only in the face-to-face interview with the clinician.

Completed

"The human retinal autofocus" – Choroidal and scleral thickness changes in response to defocus and elevation of intraocular pressure in myopia

Myopia is a widespread disorder with increasing prevalence. Despite extensive research, its pathogenesis is still poorly understood. It has been shown that the image plane of the retina can be moved forward and backward due to changes in choroidal thickness (CT), e.g. by imposed defocus. Aim of this study is to investigate the effect of imposed myopic defocus and elevation of IOP on CT and scleral thickness (ST) in human myopia using two novel optical coherence tomography (OCT) systems that operate at a longer wavelength (1060nm) compared to commercially available OCTs, allowing quantitative imaging of both CT and ST.