Clincosm LogoSign in Get a demo

YeWhi: Yellow Versus White Study

Sponsor
Hospital Hietzing (Other)
Overall Status
Completed
CT.gov ID
NCT00612781
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
17
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cataract surgery (Hoya AF-1 [UY] YA-60BB)
  • Procedure: cataract surgery (Hoya AF-1 [UV] VA-60BB lens)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Influence of Blue-Light-Filter IOLs on Color Perception and Contrast Acuity. A Randomized, Double-Masked Study With Intraindividual Comparison.
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Feb 1, 2007
Actual Study Completion Date :
May 1, 2007

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. contrast sensitivity [3 month after surgery]

    2. color vision [3 month after surgery]

    Secondary Outcome Measures

    1. visual acuity [3 month after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, Hietzing Hospital Vienna Austria 1130

    Sponsors and Collaborators

    • Hospital Hietzing

    Investigators

    • Principal Investigator: Matthias G Wirtitsch, MD, Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00612781
    Other Study ID Numbers:
    • Ye-Whi 2006
    First Posted:
    Feb 12, 2008
    Last Update Posted:
    Feb 12, 2008
    Last Verified:
    Jan 1, 2008
    Keywords provided by , ,
    intraocular lens
    blue-light filtering intraocular lens
    contrast acuity
    color vision
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Feb 12, 2008