A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01873781
First received: January 31, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Lenses, Intraocular
Contrast Sensitivity
Visual Acuity
Drug: Cyclopentolatehydrochloride

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Eearly Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score [ Time Frame: 1 study day ] [ Designated as safety issue: No ]
    To investigate the psychophysiological impact of different optical setups on visual acuity at far, intermediate and near distance.


Enrollment: 30
Study Start Date: April 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

young healthy subjects

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01873781

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1080
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, assoc. Prof. Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01873781     History of Changes
Other Study ID Numbers: OPTH-200912
Study First Received: January 31, 2013
Last Updated: August 28, 2013
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on September 16, 2014