Epiretinal Macular Membrane and Cataract Extraction
August 3, 2009 updated by: Centre Hospitalier Universitaire Dijon
Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery
The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
174
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Burgundy
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Dijon, Burgundy, France, 21000
- Ophthalmology Unit CHU Dijon
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1 Combined Surgery
|
Combined surgery for epiretinal macular membrane and cataract extraction
|
|
ACTIVE_COMPARATOR: 2 consecutive surgery
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Consecutive surgery for epiretinal macular membrane and cataract extraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (ACTUAL)
December 1, 2006
Study Completion (ACTUAL)
September 1, 2007
Study Registration Dates
First Submitted
February 25, 2009
First Submitted That Met QC Criteria
February 25, 2009
First Posted (ESTIMATE)
February 26, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 4, 2009
Last Update Submitted That Met QC Criteria
August 3, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU Dijon OPH 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.