Text Size

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
History of Changes
  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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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
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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013