Vitreous Detachment and Glaucoma Progression | NCT04719871

Studies
Vitreous Detachment and Glaucoma Progression

NCT04719871

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Jan 26, 2021Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Glaucoma
Posterior Vitreous Detachment

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Jun 2021Estimated

Completion Date

Nov 2021Estimated

First Submitted Date

Jan 18, 2021

First Submission Date that Met QC Criteria

Jan 18, 2021

First Posted Date

Jan 22, 2021Actual

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

Jan 22, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

Detailed Description

Not provided

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

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
RNFL decr	slope of decrease	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Retrospective cohort of patient with glaucoma follow in Montpellier hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Salami OSSENI, resident	Contact	65075430	33	tunde.osseni@gmail.com

Overall Officials

Name	Affiliation	Role
MAX VILLAIN, PHD	UH MONTPELLIER	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D020255	Vitreous Detachment
D018450	Disease Progression

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided