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Completed

NCT Number: NCT01165801

Size Progression of Macular Degeneration After Cataract Surgery

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Rudolph Foundation Hospital, Dept. of Ophthalmology

Vienna, State of Vienna, 1030, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cataract surgery

Procedure

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 outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Other

Collaborators

  • Medical Scientific Fund of the Mayor of Vienna

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2010
First posted
Jul 20, 2010
Registry last updated
Jul 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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