The Role of Intravitreal Glucose in Macular Thinning Foll... | NCT02210481

Studies
The Role of Intravitreal Glucose in Macular Thinning Following Surgery for Retinal Detachment or Epimacular Membrane

NCT02210481

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Nov 14, 2017Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Vitrectomy
Macular Thinning

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014Actual

Primary Completion Date

Nov 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Aug 5, 2014

First Submission Date that Met QC Criteria

Aug 5, 2014

First Posted Date

Aug 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2017

Last Update Posted Date

Nov 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GLUC-MAC-COHORT		post vitrectomy for retinal detachment or epimacular membrane patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
macular thickness measured by OCT		3 months post-operatively

Secondary Outcomes

Measure	Description	Time Frame
visual acuity		3 months post-operatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

cohort composed of patients undergoing vitrectomy for retinal detachment or epimacular membrane at Reims University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Reims		Reims		51100	France

Condition Browse Module

MeSH Terms

ID	Term
D012163	Retinal Detachment
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided