Back to resultsEpiretinal Macular Membrane and Cataract Extraction
Primary Purpose
Epiretinal Macular Membrane, Cataract Extraction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Consecutive surgery
Combined surgery
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Macular Membrane
Eligibility Criteria
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.
Sites / Locations
- Ophthalmology Unit CHU Dijon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 Combined Surgery
2 consecutive surgery
Arm Description
Outcomes
Primary Outcome Measures
Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.
Secondary Outcome Measures
Full Information
NCT ID
NCT00851760
First Posted
February 25, 2009
Last Updated
August 3, 2009
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT00851760
Brief Title
Epiretinal Macular Membrane and Cataract Extraction
Official Title
Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Macular Membrane, Cataract Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Combined Surgery
Arm Type
Experimental
Arm Title
2 consecutive surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Consecutive surgery
Intervention Description
Consecutive surgery for epiretinal macular membrane and cataract extraction
Intervention Type
Procedure
Intervention Name(s)
Combined surgery
Intervention Description
Combined surgery for epiretinal macular membrane and cataract extraction
Primary Outcome Measure Information:
Title
Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ophthalmology Unit CHU Dijon
City
Dijon
State/Province
Burgundy
ZIP/Postal Code
21000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Epiretinal Macular Membrane and Cataract Extraction
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