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Size Progression of Macular Degeneration After Cataract Surgery

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Cataract Surgery
Sponsored by
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-Related Macular Degeneration focused on measuring AMD, Cataract surgery, Size of AMD, Influence of cataract surgery on AMD Size

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Rudolph Foundation Hospital, Dept. of Ophthalmology

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Control Group (CO)

Arm Description

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.

Outcomes

Primary Outcome Measures

AMD size (defined central region of interest)
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
Cataract grade (LOCS-III), Visual acuity (distance/near), contrast acuity tests, Visual Function Index (VF-14)

Full Information

First Posted
July 17, 2010
Last Updated
July 19, 2010
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Collaborators
Medical Scientific Fund of the Mayor of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01165801
Brief Title
Size Progression of Macular Degeneration After Cataract Surgery
Official Title
Size Progression of Non-Exudative Age-Related Macular Degeneration After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Collaborators
Medical Scientific Fund of the Mayor of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD, Cataract surgery, Size of AMD, Influence of cataract surgery on AMD Size

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (CO)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
AMD size (defined central region of interest)
Description
To evaluate AMD size progression, absolute and relative differences in pixels of the ROI were cal-culated by equivalent tests.
Time Frame
at enrollment, after 6 months
Secondary Outcome Measure Information:
Title
Functional ophthalmic assessments
Description
Cataract grade (LOCS-III), Visual acuity (distance/near), contrast acuity tests, Visual Function Index (VF-14)
Time Frame
at enrollment, after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
The Rudolph Foundation Hospital, Dept. of Ophthalmology
City
Vienna
ZIP/Postal Code
1030
Country
Austria

12. IPD Sharing Statement

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Size Progression of Macular Degeneration After Cataract Surgery

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