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Epiretinal Macular Membrane and Cataract Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851760
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : August 4, 2009
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Dijon

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
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 : January 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851760


Locations
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France
Ophthalmology Unit CHU Dijon
Dijon, Burgundy, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Pr Creuzot Garcher, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT00851760    
Other Study ID Numbers: CHU Dijon OPH 01
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases