Epiretinal Macular Membrane and Cataract Extraction

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT00851760

Collaborator

(none)

174

Enrollment

Location

Arms

Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Macular Membrane Cataract Extraction	Procedure: Consecutive surgery Procedure: Combined surgery	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

174 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Combined Surgery	Procedure: Combined surgery Combined surgery for epiretinal macular membrane and cataract extraction
Active Comparator: 2 consecutive surgery	Procedure: Consecutive surgery Consecutive surgery for epiretinal macular membrane and cataract extraction

Arm

Intervention/Treatment

Experimental: 1 Combined Surgery

Procedure: Combined surgery

Combined surgery for epiretinal macular membrane and cataract extraction

Active Comparator: 2 consecutive surgery

Procedure: Consecutive surgery

Consecutive surgery for epiretinal macular membrane and cataract extraction

Outcome Measures

Primary Outcome Measures

Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology Unit CHU Dijon	Dijon	Burgundy	France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00851760

Other Study ID Numbers:

CHU Dijon OPH 01

First Posted:

Feb 26, 2009

Last Update Posted:

Aug 4, 2009

Last Verified:

Aug 1, 2009

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Aug 4, 2009