Size Progression of Macular Degeneration After Cataract Surgery

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165801
• Other study ID #: EKAM-1-2061
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2010
• Last updated: July 19, 2010
• Start date: January 2002
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2010
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Capsule Opacification
• Cataract
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Austria	The Rudolph Foundation Hospital, Dept. of Ophthalmology	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery	Medical Scientific Fund of the Mayor of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMD size (defined central region of interest)	To evaluate AMD size progression, absolute and relative differences in pixels of the ROI were cal-culated by equivalent tests.	at enrollment, after 6 months	No
Secondary	Functional ophthalmic assessments	Cataract grade (LOCS-III), Visual acuity (distance/near), contrast acuity tests, Visual Function Index (VF-14)	at enrollment, after 6 months	No