A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01873781

Enrollment

Registered

2013-06-10

Start date

2013-04-30

Completion date

2013-07-31

Last updated

2013-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Sensitivity, Lenses, Intraocular, Visual Acuity

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.

Interventions

DRUGCyclopentolatehydrochloride

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026