- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02210481
The Role of Intravitreal Glucose in Macular Thinning Following Surgery for Retinal Detachment or Epimacular Membrane (GLU-MAC)
November 9, 2017 updated by: CHU de Reims
Impact of Intravitreal Glucose Rate in Macular Thinning Following Retinal Detachment or Epimacular Membrane Surgery
Comparison between intravitreous glucose rate and macular thinning measured by Ocular Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular membrane.
Hypothesis : Association between post-operative macular thickness and intravitreous glucose rate
Study Overview
Status
Completed
Conditions
Detailed Description
Comparison between intravitreous glucose rate and macular thinning measured by OCT at 3 months post vitrectomy for retinal detachment or epimacular membrane.
The cohort is divided in 2 groups, one with the thinnest macular measurement under 190µm, and the others above 190µm.
We are looking for a correlation between increasing glucose rates and decreased macular thickness.
Study Type
Observational
Enrollment (Actual)
60
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
-
-
-
Reims, France, 51100
- Centre Hospitalier Universitaire de Reims
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
cohort composed of patients undergoing vitrectomy for retinal detachment or epimacular membrane at Reims University Hospital
Description
Inclusion Criteria:
- patient who underwent vitrectomy for retinal detachment or epimacular membrane
Exclusion Criteria:
- patient suffering of diabetes,
- recurrence of retinal detachment,
- age-related macular degeneration,
- post surgical macular oedema
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
Cohorts and Interventions
Group / Cohort |
|---|
|
GLUC-MAC-COHORT
post vitrectomy for retinal detachment or epimacular membrane patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
macular thickness measured by OCT
Time Frame: 3 months post-operatively
|
3 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
visual acuity
Time Frame: 3 months post-operatively
|
3 months post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
February 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
August 5, 2014
First Submitted That Met QC Criteria
August 5, 2014
First Posted (Estimate)
August 6, 2014
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 9, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOL2010-02
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.
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