NCT00612781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
Last Updated

February 12, 2008

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

January 29, 2008

Last Update Submit

January 29, 2008

Conditions

Cataract

Keywords

intraocular lensblue-light filtering intraocular lenscontrast acuitycolor vision

Outcome Measures

Primary Outcomes (2)

  • contrast sensitivity

    3 month after surgery

  • color vision

    3 month after surgery

Secondary Outcomes (1)

  • visual acuity

    3 month after surgery

Study Arms (2)

A

OTHER
Procedure: cataract surgery (Hoya AF-1 [UY] YA-60BB)

B

OTHER
Procedure: cataract surgery (Hoya AF-1 [UV] VA-60BB lens)

Interventions

cataract surgery (Hoya AF-1 [UY] YA-60BB)PROCEDURE

implantation of a yellow Hoya AF-1 (UY) YA-60BB intraocular lens

Also known as: Hoya AF-1 (UY) YA-60BB
A
cataract surgery (Hoya AF-1 [UV] VA-60BB lens)PROCEDURE

implantation of an uncoloured Hoya AF-1 (UV) VA-60BB

Also known as: Hoya AF-1 (UV) VA-60BB
B

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bilateral age-related cataract
  • age 55 to 80 years
  • expected postoperative visual acuity of at least 1.0

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Hietzing Hospital

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Matthias G Wirtitsch, MD

    Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 12, 2008

Study Start

December 1, 2005

Primary Completion

February 1, 2007

Study Completion

May 1, 2007

Last Updated

February 12, 2008

Record last verified: 2008-01

Locations

AU(1)