A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

Completed

• Conditions: Lenses, Intraocular; Contrast Sensitivity; Visual Acuity
• Interventions: Drug: Cyclopentolatehydrochloride

• Registration Number: NCT01873781
• Lead Sponsor: Medical University of Vienna

Brief Summary

Age related cataracts are responsible for about 51 percent of blindness worldwide and according to the WHO affect about 20 million people, according to the WH . As cataract surgery is firstline treatment in the western world, there is a constant attempt to improve artificial intraocular lenes (IOL).

As for this study, the investigators seek to compare four different IOL designs in in a psychophysiological setting, allowing to assess the impact of these IOLs on vision and psychological processing of visual information.

As these IOLs also have downsides, such as reduced light intensity or image alterations, the subjective preference and overall impression shall be investigated. The healthy subjects look through a stable spectacle frame mounted onto a table, which enables the investigator to insert the different IOLs. This would allow subjective testing of IOLs before surgery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-31
• Study Start: 2013-04
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-10
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-29

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, between -1 and +1 diopters

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Exclusion Criteria

• > 0,5 diopters of cylinder
• 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: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
30 healthy male and female subjects	Cyclopentolatehydrochloride	30 healthy male and female subjects aged 18-35

Primary Outcome Measures

Name	Time	Method
Eearly Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score	1 study day	To investigate the psychophysiological impact of different optical setups on visual acuity at far, intermediate and near distance.

Trial Locations

Locations (1)

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