Size Progression of Macular Degeneration After Cataract Surgery

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)

Overall Status

Completed

CT.gov ID

NCT01165801

Collaborator

Medical Scientific Fund of the Mayor of Vienna (Other)

Enrollment

Location

Arm

101.9

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Procedure: Cataract Surgery	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Size Progression of Non-Exudative Age-Related Macular Degeneration After Cataract Surgery

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

AMD size (defined central region of interest) [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.