A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

Medical University of Vienna (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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.

Study Design

Study Type:
Actual Enrollment :
30 participants
Observational Model:
Time Perspective:
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria


Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1080

Sponsors and Collaborators

  • Medical University of Vienna


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Gerhard Garhofer, assoc. Prof. Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • OPTH-200912
First Posted:
Jun 10, 2013
Last Update Posted:
Aug 29, 2013
Last Verified:
Aug 1, 2013
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2013