A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873781
• Other study ID #: OPTH-200912
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: August 28, 2013
• Start date: April 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contrast Sensitivity
• Lenses, Intraocular
• Visual Acuity

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No