Yellow Versus White Study (YeWhi)

January 29, 2008 updated by: Hospital Hietzing

Influence of Blue-Light-Filter IOLs on Color Perception and Contrast Acuity. A Randomized, Double-Masked Study With Intraindividual Comparison.

Blue-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of blue-light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of a blue-light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • Austria
      • Vienna, Austria, 1130
        • Department of Ophthalmology, Hietzing Hospital

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

53 years to 78 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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
Procedure: cataract surgery (Hoya AF-1 [UY] YA-60BB)
implantation of a yellow Hoya AF-1 (UY) YA-60BB intraocular lens
Other Names:
  • Hoya AF-1 (UY) YA-60BB
Other: B
Procedure: cataract surgery (Hoya AF-1 [UV] VA-60BB lens)
implantation of an uncoloured Hoya AF-1 (UV) VA-60BB
Other Names:
  • Hoya AF-1 (UV) VA-60BB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
contrast sensitivity
Time Frame: 3 month after surgery
3 month after surgery
color vision
Time Frame: 3 month after surgery
3 month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
visual acuity
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

Hospital Hietzing

Investigators

  • Principal Investigator: Matthias G Wirtitsch, 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

December 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

May 1, 2007

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)

February 12, 2008

Last Update Submitted That Met QC Criteria

January 29, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ye-Whi 2006

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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