Size Progression of Macular Degeneration After Cataract Surgery

This study has been completed.

First Received on July 17, 2010. Last Updated on July 19, 2010 History of Changes

Sponsor:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Collaborator:	Medizinisch-wissenschaftlicher Fonds des Bürgermeisters der Stadt Wien, that is, Scientific Fund of the Major of the City of Vienna
Information provided by:	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:	NCT01165801

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 IV

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Cataract Macular Degeneration

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

Medizinisch-wissenschaftlicher Fonds des Bürgermeisters der Stadt Wien, that is, Scientific Fund of the Major of the City 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 February 09, 2012