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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014