Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.

NCT ID: NCT05053698

Last Updated: 2021-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-03

Study Completion Date

2021-06-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients :

* Group 1 : 48 eyes primarily treated with gas tamponade
* Group 2 : 11 eyes primarily treated with silicone oil tamponade
* Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse
* Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Detachment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Initial gas tamponade

Primary vitrectomy and fluid-air exchange with SF6 or C2F6 gas tamponade

Aqueous flare measurement

Intervention Type OTHER

Aqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan).

Initial silicone oil tamponade

Primary vitrectomy and fluid-air exchange with silicone oil tamponade

Aqueous flare measurement

Intervention Type OTHER

Aqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan).

Relapse treated with gas tamponade

Secondary vitrectomy and fluid-air exchange with SF6 or C2F6 or C3F8 gas tamponade

Aqueous flare measurement

Intervention Type OTHER

Aqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan).

Relapse treated with silicone oil tamponade

Secondary vitrectomy and fluid-air exchange with silicone oil tamponade

Aqueous flare measurement

Intervention Type OTHER

Aqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aqueous flare measurement

Aqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult patients
* patients who underwent surgery for rhegmatogenous retinal detachment (silicone or gas tamponade)
* aqueous flare measurement carried out preoperatively and postoperatively at 2-4 weeks and 3 months

Exclusion Criteria

* diabetic retinopathy
* glaucoma
* non rhegmatogenous retinal detachment
* active uveitis
* pseudoexfoliation syndrome.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

BERROD Jean-Paul

Professor BERROD Jean-Paul

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Paul BERROD, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BERROD Jean-Paul MD

Nancy, Grand Est, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020PI209

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

1ry Versus 2ry ILM Peeling in RD
NCT07346560 RECRUITING NA
REtinal Detachment Outcomes Study
NCT05863312 RECRUITING NA