NCT00612729

Brief Summary

Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of two 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
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2008

Typical duration for phase_4

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

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
3 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 17, 2010

Status Verified

December 1, 2008

Enrollment Period

1.5 years

First QC Date

January 29, 2008

Last Update Submit

August 16, 2010

Conditions

Cataract

Keywords

intraocular lenslight filtering intraocular lenscontrast acuitycolor vision

Outcome Measures

Primary Outcomes (1)

  • contrast acuity

    3 month after surgery

Secondary Outcomes (2)

  • visual acuity and color vision

    3 month after surgery

  • colour perception

    3 month after surgery

Interventions

Polylens Y30 intraocular lensPROCEDURE

cataract surgery

Orange Series Model PC 440 Y intraocular lensPROCEDURE

cataract surgery

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

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Matthias G Wirtitsch, MD

    Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria

    PRINCIPAL INVESTIGATOR

  • Nadja Karnik, MD

    Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria

    STUDY CHAIR

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

May 1, 2008

Primary Completion

November 1, 2009

Study Completion

June 1, 2010

Last Updated

August 17, 2010

Record last verified: 2008-12

Locations

AU(1)