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Yellow Versus White Study (YeWhi)

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ClinicalTrials.gov Identifier: NCT00612781
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : February 12, 2008
Sponsor:
Information provided by:

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
Cataract 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  (Clinical Trial)
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 : December 2005
Primary Completion Date : February 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. contrast sensitivity [ Time Frame: 3 month after surgery ]
  2. color vision [ Time Frame: 3 month after surgery ]

Secondary Outcome Measures :
  1. visual acuity [ Time Frame: 3 month after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: February 12, 2008
Last Verified: January 2008

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