A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

NCT01873781 | Completed

• 1 other identifier: OPTH-200912
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lenses, Intraocular; Contrast Sensitivity; Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

30 healthy male and female subjects

30 healthy male and female subjects aged 18-35

Drug: Cyclopentolatehydrochloride

Interventions

Cyclopentolatehydrochloride DRUG

Cyclopentolatehydrochloride 0.5% (Thilo, Alcon, Vienna), dose: 1 drop for study eye

30 healthy male and female subjects

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

young healthy subjects

You may qualify if:

• 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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1080, Austria

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. Prof. Dr.med.univ.

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: June 10, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

AU (1)