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

This study has been completed.
Sponsor:
Information provided by:
Hospital Hietzing
ClinicalTrials.gov Identifier:
NCT00612729
First received: January 29, 2008
Last updated: August 16, 2010
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Cataract
Procedure: Polylens Y30 intraocular lens
Procedure: Orange Series Model PC 440 Y intraocular lens
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Light-filters in IOLs on Color Perception and Contrast Acuity. A Randomized, Double-masked Study With Intraindividual Comparison.

Resource links provided by NLM:


Further study details as provided by Hospital Hietzing:

Primary Outcome Measures:
  • contrast acuity [ Time Frame: 3 month after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • visual acuity and color vision [ Time Frame: 3 month after surgery ] [ Designated as safety issue: No ]
  • colour perception [ Time Frame: 3 month after surgery ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Polylens Y30 intraocular lens
    cataract surgery
    Procedure: Orange Series Model PC 440 Y intraocular lens
    cataract surgery
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612729

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
Study Chair: Nadja Karnik, MD Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria
  More Information

No publications provided

Responsible Party: Matthias Wirtitsch MD, Dept. of Ophthalmology, Hospital Hietzing, Vienna, Austria
ClinicalTrials.gov Identifier: NCT00612729     History of Changes
Other Study ID Numbers: Ye-Or 2008
Study First Received: January 29, 2008
Last Updated: August 16, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Hospital Hietzing:
intraocular lens
light filtering intraocular lens
contrast acuity
color vision

ClinicalTrials.gov processed this record on September 16, 2014