search
Back to results

Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Polylens Y30 intraocular lens
Orange Series Model PC 440 Y intraocular lens
Sponsored by
Hospital Hietzing
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring intraocular lens, 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

Outcomes

Primary Outcome Measures

contrast acuity

Secondary Outcome Measures

visual acuity and color vision
colour perception

Full Information

First Posted
January 29, 2008
Last Updated
August 16, 2010
Sponsor
Hospital Hietzing
search

1. Study Identification

Unique Protocol Identification Number
NCT00612729
Brief Title
Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.
Official Title
Influence of Light-filters in IOLs on Color Perception and Contrast Acuity. A Randomized, Double-masked Study With Intraindividual Comparison.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Hietzing

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Prospective, randomized, double-masked study with intraindividual comparison. Implantation of a Polylens Y30 IOL in one eye and an Orange Series Model PC 440 Y in the contralateral eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
intraocular lens, 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
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Polylens Y30 intraocular lens
Intervention Description
cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Orange Series Model PC 440 Y intraocular lens
Intervention Description
cataract surgery
Primary Outcome Measure Information:
Title
contrast acuity
Time Frame
3 month after surgery
Secondary Outcome Measure Information:
Title
visual acuity and color vision
Time Frame
3 month after surgery
Title
colour perception
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
First Name & Middle Initial & Last Name & Degree
Nadja Karnik, MD
Organizational Affiliation
Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Ophthalmology, Hietzing Hospital
City
Vienna
ZIP/Postal Code
1130
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.

We'll reach out to this number within 24 hrs