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

Not Applicable

Completed

• Conditions: Lenses; Intraocular Sensitivity; Visual Acuity
• Interventions: Drug: Cyclopentolatehydrochloride 0,5% eye drops

• Registration Number: NCT02409641
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-24
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-07
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
30 healthy male and female subjects	Cyclopentolatehydrochloride 0,5% eye drops	30 healthy male and female subjects , age 18-35 years

Primary Outcome Measures

Name	Time	Method
Visual Acuity measured by Early Treatment of Diabetic Retinopathy Study Chart	1 study day

Secondary Outcome Measures

Name	Time	Method
Contrast Sensitivity measured by Pelli-Robson Contrast Sensitivity Chart	1 study day

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria