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Yellow Versus White Study (YeWhi)

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
cataract surgery (Hoya AF-1 [UY] YA-60BB)
cataract surgery (Hoya AF-1 [UV] VA-60BB lens)
Sponsored by
Hospital Hietzing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring intraocular lens, blue-light filtering intraocular lens, contrast acuity, color vision

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, Hietzing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

contrast sensitivity
color vision

Secondary Outcome Measures

visual acuity

Full Information

First Posted
January 29, 2008
Last Updated
January 29, 2008
Sponsor
Hospital Hietzing
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1. Study Identification

Unique Protocol Identification Number
NCT00612781
Brief Title
Yellow Versus White Study
Acronym
YeWhi
Official Title
Influence of Blue-Light-Filter IOLs on Color Perception and Contrast Acuity. A Randomized, Double-Masked Study With Intraindividual Comparison.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Hietzing

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
intraocular lens, blue-light filtering intraocular lens, contrast acuity, color vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Title
B
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
cataract surgery (Hoya AF-1 [UY] YA-60BB)
Other Intervention Name(s)
Hoya AF-1 (UY) YA-60BB
Intervention Description
implantation of a yellow Hoya AF-1 (UY) YA-60BB intraocular lens
Intervention Type
Procedure
Intervention Name(s)
cataract surgery (Hoya AF-1 [UV] VA-60BB lens)
Other Intervention Name(s)
Hoya AF-1 (UV) VA-60BB
Intervention Description
implantation of an uncoloured Hoya AF-1 (UV) VA-60BB
Primary Outcome Measure Information:
Title
contrast sensitivity
Time Frame
3 month after surgery
Title
color vision
Time Frame
3 month after surgery
Secondary Outcome Measure Information:
Title
visual acuity
Time Frame
3 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias G Wirtitsch, MD
Organizational Affiliation
Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Hietzing Hospital
City
Vienna
ZIP/Postal Code
1130
Country
Austria

12. IPD Sharing Statement

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Yellow Versus White Study

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