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Size Progression of Macular Degeneration After Cataract Surgery

This study has been completed.
Sponsor:
Collaborator:
Medical Scientific Fund of the Mayor of Vienna
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT01165801
First received: July 17, 2010
Last updated: July 19, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Age-Related Macular Degeneration
 Procedure: Cataract Surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Size Progression of Non-Exudative Age-Related Macular Degeneration After Cataract Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • AMD size (defined central region of interest) [ Time Frame: at enrollment, after 6 months ] [ Designated as safety issue: No ]
    To evaluate AMD size progression, absolute and relative differences in pixels of the ROI were cal-culated by equivalent tests.


Secondary Outcome Measures:
  • Functional ophthalmic assessments [ Time Frame: at enrollment, after 6 months ] [ Designated as safety issue: No ]
    Cataract grade (LOCS-III), Visual acuity (distance/near), contrast acuity tests, Visual Function Index (VF-14)


Enrollment: 54
Study Start Date: January 2002
Study Completion Date: July 2010
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165801

Locations
Austria
The Rudolph Foundation Hospital, Dept. of Ophthalmology
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Medical Scientific Fund of the Mayor of Vienna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01165801     History of Changes
Other Study ID Numbers: EKAM-1-2061
Study First Received: July 17, 2010
Last Updated: July 19, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
AMD
Cataract surgery
Size of AMD
Influence of cataract surgery on AMD Size

Additional relevant MeSH terms:
Macular Degeneration
Cataract
Geographic Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 21, 2013