A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Visual Acuity; Lenses, Intraocular; Contrast Sensitivity
• Intervention / Treatment: Drug: Cyclopentolatehydrochloride

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1080
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

young healthy subjects

Description

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
30 healthy male and female subjects; 30 healthy male and female subjects aged 18-35	Drug: Cyclopentolatehydrochloride; Cyclopentolatehydrochloride 0.5% (Thilo, Alcon, Vienna), dose: 1 drop for study eye

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (ESTIMATE): June 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 29, 2013
• Last Update Submitted That Met QC Criteria: August 28, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: OPTH-200912