Vitreous Detachment and Glaucoma Progression (REVEAL)

January 22, 2021 updated by: University Hospital, Montpellier

Rate of Visual Field Progression Before and After Posterior Vitreous Detachment

Posterior vitreous detachment is a common event. With optical coherence tomography, the investigators can precisely follow the stage of posterior vitrous detachment. In this study, the investigators investigate if the loss of contact between the vitreous and the fovea is the start of glaucoma progression.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective cohort of patient with glaucoma follow in Montpellier hospital

Description

Inclusion criteria:

  • Patient with glaucoma
  • at least 4 years of follow up
  • at least 6 visual fields
  • at least 4 optical coherence tomographies

Exclusion criteria:

  • pars plana vitrectomy
  • others ophtalmological or neurological disease which can modify visual fields

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
with posterior vitreous detachment
patient with stage 3 or more of posterior vitreous detachment on optical coherence tomography
without posterior vitreous detachment
patient with stage 2 or less of posterior vitreous detachment on optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glaucoma progression
Time Frame: 1 day
glaucoma progression based on analysis of visual fields
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNFL decr
Time Frame: 1 day
slope of decrease
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: MAX VILLAIN, PHD, UH Montpellier

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)

October 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0696

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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