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

Tracking Information
First Received Date ^ICMJE	July 17, 2010
Last Updated Date	July 19, 2010
Start Date ^ICMJE	January 2002
Primary Completion Date	September 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 19, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01165801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 19, 2010)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Size Progression of Macular Degeneration After Cataract Surgery
Official Title ^ICMJE	Size Progression of Non-Exudative Age-Related Macular Degeneration After Cataract Surgery
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Age-Related Macular Degeneration
Intervention ^ICMJE	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.
Study Arm (s)	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. Intervention: Procedure: Cataract Surgery
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	54
Completion Date	July 2010
Primary Completion Date	September 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria

Administrative Information
NCT Number ^ICMJE	NCT01165801
Other Study ID Numbers ^ICMJE	EKAM-1-2061
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Collaborators ^ICMJE	Medical Scientific Fund of the Mayor of Vienna
Investigators ^ICMJE	Not Provided
Information Provided By	The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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