Size Progression of Macular Degeneration After Cataract Surgery

Overview

The purpose of this study was to find out if in patients with non-exudative age-related macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression or progression to exudative AMD could be detected 6 months after surgery.

Full Title of Study: “Size Progression of Non-Exudative Age-Related Macular Degeneration After Cataract Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2007

Interventions

  • Procedure: Cataract Surgery
    • Fifty-four patients with cataract and non-exudative age-related macular degeneration (AMD) were randomized into an early surgery group (ES=28) with immediate cataract surgery and a control group (CO=26) where surgery was performed after six months.

Arms, Groups and Cohorts

  • No Intervention: Control Group (CO)
    • Fifty-four patients with cataract and non-exudative age-related macular degeneration (AMD) were randomized into an early surgery group (ES=28) with immediate cataract surgery and a control group (CO=26) where surgery was performed after six months.

Clinical Trial Outcome Measures

Primary Measures

  • AMD size (defined central region of interest)
    • Time Frame: at enrollment, after 6 months
    • To evaluate AMD size progression, absolute and relative differences in pixels of the ROI were cal-culated by equivalent tests.

Secondary Measures

  • Functional ophthalmic assessments
    • Time Frame: at enrollment, after 6 months
    • Cataract grade (LOCS-III), Visual acuity (distance/near), contrast acuity tests, Visual Function Index (VF-14)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with cataract and non-exudative age-related macular degeneration Exclusion Criteria:

  • Patients with retinal pathologies other than AMD, exudative AMD, progressive glaucoma, myopia > 10 diopters, panretinal laser treatment, former cataract or vitreoretinal surgery, were excluded.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
  • Collaborator
    • Medical Scientific Fund of the Mayor of Vienna

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