- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00612729
Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.
August 16, 2010 updated by: Hospital Hietzing
Influence of Light-filters in IOLs on Color Perception and Contrast Acuity. A Randomized, Double-masked Study With Intraindividual Comparison.
Visible-light-filtering IOLs are implanted increasingly often in cataract surgery.
Several studies examined the effect of light-filters on contrast and colour vision.
However, the study outcomes were varying.
The present study investigated the effect of two light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prospective, randomized, double-masked study with intraindividual comparison.
Implantation of a Polylens Y30 IOL in one eye and an Orange Series Model PC 440 Y in the contralateral eye.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Vienna, Austria, 1130
- Department of Ophthalmology, Hietzing Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- bilateral age-related cataract
- age 55 to 80 years
- expected postoperative visual acuity of at least 1.0
Exclusion Criteria:
- amblyopia
- corneal scars
- diabetes
- arterial hypertonia
- pseudoexfoliation-syndrome
- earlier ocular surgeries or laser treatments
- intraocular tumors
- color abnormalities
- expected postoperative visual acuity lower 1.0
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
contrast acuity
Time Frame: 3 month after surgery
|
3 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
visual acuity and color vision
Time Frame: 3 month after surgery
|
3 month after surgery
|
colour perception
Time Frame: 3 month after surgery
|
3 month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthias G Wirtitsch, MD, Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria
- Study Chair: Nadja Karnik, MD, Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
January 29, 2008
First Submitted That Met QC Criteria
January 29, 2008
First Posted (Estimate)
February 12, 2008
Study Record Updates
Last Update Posted (Estimate)
August 17, 2010
Last Update Submitted That Met QC Criteria
August 16, 2010
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ye-Or 2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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