GlaucomaREVEALNCT04719871
Vitreous Detachment and Glaucoma Progression
An observational study of Glaucoma and Posterior Vitreous Detachment, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma, Posterior Vitreous Detachment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective cohort of patient with glaucoma follow in Montpellier hospital
Who may be able to join
- Patient with glaucoma
- at least 4 years of follow up
- at least 6 visual fields
- at least 4 optical coherence tomographies
Who cannot join
- pars plana vitrectomy
- others ophtalmological or neurological disease which can modify visual fields
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Max VILLAIN, PhD, 04 67 33 78 79 ext. 33, ophtalmo@chu-montpellier.fr
About this study
Official title: 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.
- Conditions
- Glaucoma, Posterior Vitreous Detachment
- Keywords
- Glaucoma, Vitreous, Progression
- Medical subject headings
- Glaucoma, Vitreous Detachment, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Glaucoma progression
glaucoma progression based on analysis of visual fields
Measured: 1 day
Secondary outcomes (1)
RNFL decr
slope of decrease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Oct 2020
- Primary completionJun 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAX VILLAIN, PHD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719871
- Sponsor's protocol ID
- RECHMPL20_0696
- Acronym
- REVEAL
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Visual Field Progression Before and After Posterior Vitreous Detachment
- ClinicalTrials.gov ID
- NCT04719871
- Acronym / sponsor ID
- REVEAL / RECHMPL20_0696
- Conditions
- Glaucoma, Posterior Vitreous Detachment
- Keywords
- Glaucoma, Vitreous, Progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort of patient with glaucoma follow in Montpellier hospital
Key inclusion criteria (4 listed)
- Patient with glaucoma
- at least 4 years of follow up
- at least 6 visual fields
- at least 4 optical coherence tomographies
Key exclusion criteria (2 listed)
- pars plana vitrectomy
- others ophtalmological or neurological disease which can modify visual fields
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glaucoma progression
Time frame: 1 day
glaucoma progression based on analysis of visual fields
1 secondary outcome
RNFL decr
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAX VILLAIN, PHD study director
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Posterior Vitreous Detachment, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salami OSSENI, resident (65075430 ext. 33, tunde.osseni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glaucoma progression (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.