Yellow Versus White Study (YeWhi)

This study has been completed.
Sponsor:
Information provided by:
Hospital Hietzing
ClinicalTrials.gov Identifier:
NCT00612781
First received: January 29, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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 Intervention Phase
Cataract
Procedure: cataract surgery (Hoya AF-1 [UY] YA-60BB)
Procedure: cataract surgery (Hoya AF-1 [UV] VA-60BB lens)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Hospital Hietzing:

Primary Outcome Measures:
  • contrast sensitivity [ Time Frame: 3 month after surgery ] [ Designated as safety issue: Yes ]
  • color vision [ Time Frame: 3 month after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • visual acuity [ Time Frame: 3 month after surgery ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2005
Study Completion Date: May 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Procedure: cataract surgery (Hoya AF-1 [UY] YA-60BB)
implantation of a yellow Hoya AF-1 (UY) YA-60BB intraocular lens
Other Name: Hoya AF-1 (UY) YA-60BB
B Procedure: cataract surgery (Hoya AF-1 [UV] VA-60BB lens)
implantation of an uncoloured Hoya AF-1 (UV) VA-60BB
Other Name: Hoya AF-1 (UV) VA-60BB

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612781

Locations
Austria
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
  More Information

No publications provided

Responsible Party: Matthias Wirtitsch MD, Dept. of Ophthalmology, Hospital Hietzing, Vienna, Austria
ClinicalTrials.gov Identifier: NCT00612781     History of Changes
Other Study ID Numbers: Ye-Whi 2006
Study First Received: January 29, 2008
Last Updated: January 29, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Hospital Hietzing:
intraocular lens
blue-light filtering intraocular lens
contrast acuity
color vision

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014