NCT05053698

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

June 4, 2021

Last Update Submit

September 14, 2021

Conditions

Retinal Detachment

Keywords

Aqueous FlareRetinal Detachment

Outcome Measures

Primary Outcomes (1)

  • Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter)

    Aqueous flare was measured preoperatively and postoperatively at 2 weeks, 4 weeks and 3 months with a laser flare-cell meter, in patients treated for RRD

    preoperatively and postoperatively at 2 weeks and 3 months after surgery

Secondary Outcomes (5)

  • Change in aqueous flare measurement (measured with a laser flare-cell meter)

    postoperatively at 2 weeks and 3 months after surgery

  • Comparison of aqueous flare values (measured with a laser flare-cell meter) between patients who relapsed and patients who didn't relapse

    preoperative

  • Evolution of measures of visual acuity

    preoperatively and postoperatively at 3 months

  • Evolution of macular status

    preoperatively and postoperatively at 3 months

  • Relapsing status (yes or not)

    at 3 months postoperative

Study Arms (4)

Initial gas tamponade

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

Other: Aqueous flare measurement

Initial silicone oil tamponade

Primary vitrectomy and fluid-air exchange with silicone oil tamponade

Other: Aqueous flare measurement

Relapse treated with gas tamponade

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

Other: Aqueous flare measurement

Relapse treated with silicone oil tamponade

Secondary vitrectomy and fluid-air exchange with silicone oil tamponade

Other: Aqueous flare measurement

Interventions

Aqueous flare measurementOTHER

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

Initial gas tamponadeInitial silicone oil tamponadeRelapse treated with gas tamponadeRelapse treated with silicone oil tamponade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients addressed at the Ophthalmology Department for Rhegmatogenous Retinal Detachment and who matched the inclusion criteria.

You may qualify if:

  • 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

You may not qualify if:

  • diabetic retinopathy
  • glaucoma
  • non rhegmatogenous retinal detachment
  • active uveitis
  • pseudoexfoliation syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BERROD Jean-Paul MD

Nancy, Grand Est, 54000, France

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Jean-Paul BERROD, Professor MD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor BERROD Jean-Paul

Study Record Dates

First Submitted

June 4, 2021

First Posted

September 22, 2021

Study Start

June 3, 2020

Primary Completion

June 4, 2021

Study Completion

June 4, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)