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CompletedNCT05053698FLADESILUpdated Sep 22, 2021

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

An observational study in Retinal Detachment, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-22.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Retinal Detachment

Keywords

  • Aqueous Flare
  • Retinal Detachment
03

In context

Retinal Detachment

207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.

This study's enrollment of 48 is below the median of 64 across 60 observational studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • diabetic retinopathy
  • glaucoma
  • non rhegmatogenous retinal detachment
  • active uveitis
  • pseudoexfoliation syndrome.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
48 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherAqueous flare measurement

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

06

What researchers measure

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

    Time frame: preoperatively and postoperatively at 2 weeks and 3 months after surgery

Secondary outcomes

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

    To describe the evolution of the aqueous humor flare between the postoperative visits at 2 weeks and at 3 months after retinal detachment surgery in each groups of patients.

    Time frame: postoperatively at 2 weeks and 3 months after surgery

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

    To compare the preoperative flare measurements between patients without versus with recurrence among those treated with gas

    Time frame: preoperative

  3. Evolution of measures of visual acuity

    The best-corrected visual acuity (BCVA) was measured with projected-light Snellen charts and expressed in logMAR.

    Time frame: preoperatively and postoperatively at 3 months

  4. Evolution of macular status

    Evaluation of macular status with macular imaging by optical coherence tomography (Heidelberg Engineering)

    Time frame: preoperatively and postoperatively at 3 months

  5. Relapsing status (yes or not)

    Determined by careful fundus and peripheral retina examination.

    Time frame: at 3 months postoperative

07

Study locations

1 site
  • BERROD Jean-Paul MD
    Nancy, Grand EST 54000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05053698
Lead sponsor
Central Hospital, Nancy, France
Responsible party
BERROD Jean-Paul (Professor BERROD Jean-Paul, Central Hospital, Nancy, France) — Principal investigator
First posted
Sep 22, 2021
Start date
Jun 3, 2020
Primary completion
Jun 4, 2021
Completion
Jun 4, 2021
Last update
Sep 22, 2021

Study contacts

Jean-Paul BERROD, Professor MD
principal investigator · Central Hospital, Nancy, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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