Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 17, 2010
July 19, 2010
January 2002
September 2007   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01165801 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Size Progression of Macular Degeneration After Cataract Surgery
Size Progression of Non-Exudative Age-Related 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Age-Related Macular Degeneration
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
July 2010
September 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01165801
EKAM-1-2061
No
Not Provided
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Medical Scientific Fund of the Mayor of Vienna
Not Provided
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP