Yellow Versus White Study | NCT00612781

Studies
Yellow Versus White Study

NCT00612781

Sponsor

Hospital Hietzing

Status

Completed

Last Update Posted

Feb 12, 2008Estimated

Enrollment

24Actual

Phase

Phase 4

Conditions

Cataract

Interventions

cataract surgery (Hoya AF-1 [UY] YA-60BB)
cataract surgery (Hoya AF-1 [UV] VA-60BB lens)

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Feb 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Jan 29, 2008

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Feb 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2008

Last Update Posted Date

Feb 12, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Other		Procedure: cataract surgery (Hoya AF-1 [UY] YA-60BB)
B	Other		Procedure: cataract surgery (Hoya AF-1 [UV] VA-60BB lens)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cataract surgery (Hoya AF-1 [UY] YA-60BB)	Procedure	implantation of a yellow Hoya AF-1 (UY) YA-60BB intraocular lens	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
contrast sensitivity		3 month after surgery
color vision		3 month after surgery

Secondary Outcomes

Measure	Description	Time Frame
visual acuity		3 month after surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias G Wirtitsch, MD	Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Hietzing Hospital		Vienna		1130	Austria

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002387	Cataract Extraction

Ancestor Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided