A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality

Study Overview
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Brief Summary
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The WHO, states that age related cataracts account for 51 percent of worldwide blindness and affect about 20 million people. Surgery with intraocular lens (IOL) implantation is the first line treatment for cataracts, thus there is an on going effort to improve IOL design and performance. It is planned to compare three different IOL designs in a psychophysical test setting. Most IOL testing is done in 2D scenarios such as Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity or contrast sensitivity testing. The use of 3D scenario would allow testing a more real-life situation. As various downsides of different IOL designs have been reported, testing of IOLs before surgical implantation is a promising approach to maximise patient satisfaction. Known deficiencies include amongst others reduced contrast sensitivity or light intensity. To test three different IOL designs, it is planned to have 2D healthy young subjects look through a stable, table mounted spectacle frame, in which the different IOLs can be inserted. This allows for subjective testing of IOL's in a 2D and 3D scenario.

Official Title
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A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality

Conditions
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Lenses, Intraocular Sensitivity, Visual Acuity

Intervention / Treatment
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* Drug: Cyclopentolatehydrochloride 0,5% eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 18 and 35 years Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings Refractive spherical error between between -1 and +1 diopters, refractive cylindrical error between -0,25 and +0,25 diopters Dominant eye : right eye ( used as study eye) Exclusion Criteria: Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 healthy male and female subjects<br>30 healthy male and female subjects , age 18-35 years | Drug: Cyclopentolatehydrochloride 0,5% eye drops<br>* 1 drop in study eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity measured by Early Treatment of Diabetic Retinopathy Study Chart |  | 1 study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Sensitivity measured by Pelli-Robson Contrast Sensitivity Chart |  | 1 study day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOL