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

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ClinicalTrials.gov Identifier: NCT00612729
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:
Hospital Hietzing

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : May 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Procedure: Polylens Y30 intraocular lens
    cataract surgery
    Procedure: Orange Series Model PC 440 Y intraocular lens
    cataract surgery

Outcome Measures
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Primary Outcome Measures :
  1. contrast acuity [ Time Frame: 3 month after surgery ]

Secondary Outcome Measures :
  1. visual acuity and color vision [ Time Frame: 3 month after surgery ]
  2. colour perception [ Time Frame: 3 month after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: August 17, 2010
Last Verified: December 2008

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases