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NCT00851760 Clinical Trial

Epiretinal Macular Membrane and Cataract Extraction

Cataract Extraction Clinical Trial

Official title:
Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00851760
Other study ID # CHU Dijon OPH 01
Secondary ID
Status Completed
Phase N/A
First received February 25, 2009
Last updated August 3, 2009
Start date January 2005
Est. completion date September 2007

Study information
Verified date August 2009
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.

Description:

A retrospective nonrandomized clinical case series study collected 174 consecutive eyes of 174 patients undergoing macular surgery between January 2005 and December 2006. Patients suffering from epiretinal macular membranes (ERM) secondary to uveitis, trauma, or associated with a simultaneous retinal detachment (RD) were excluded. We treated 109 eyes with a combined procedure (group 1) and 65 eyes with a consecutive surgery (membrane surgery and cataract separately)(group 2).

Recruitment information / eligibility
Status Completed
Enrollment 174
Est. completion date September 2007
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria:

- All patients had symptomatic visual loss and needed vitrectomy for ERM removal.

Exclusion Criteria:

- Patients suffering from ERM secondary to uveitis, trauma, or associated with a simultaneous RD were excluded.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Consecutive surgery
Consecutive surgery for epiretinal macular membrane and cataract extraction
• Combined surgery
Combined surgery for epiretinal macular membrane and cataract extraction

Locations
Country Name City State
France Ophthalmology Unit CHU Dijon Dijon Burgundy

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures. No
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