Yellow Versus White Study - Full Text View

Sponsored by:	Hospital Hietzing
Information provided by:	Hospital Hietzing
ClinicalTrials.gov Identifier:	NCT00612781

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 IV

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Official Title:	Influence of Blue-Light-Filter IOLs on Color Perception and Contrast Acuity. A Randomized, Double-Masked Study With Intraindividual Comparison.

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
B	Procedure: cataract surgery (Hoya AF-1 [UV] VA-60BB lens) implantation of an uncoloured 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

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

Keywords provided by Hospital Hietzing:

intraocular lens
blue-light filtering intraocular lens
contrast acuity
color vision

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on February 05, 2009