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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05053698
Acronym
FLADESIL
Enrollment
48
Registered
2021-09-22
Start date
2020-06-03
Completion date
2021-06-04
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Keywords

Aqueous Flare, Retinal Detachment

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

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).

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter)preoperatively and postoperatively at 2 weeks and 3 months after surgeryAqueous 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

Secondary

MeasureTime frameDescription
Change in aqueous flare measurement (measured with a laser flare-cell meter)postoperatively at 2 weeks and 3 months after surgeryTo 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.
Comparison of aqueous flare values (measured with a laser flare-cell meter) between patients who relapsed and patients who didn't relapsepreoperativeTo compare the preoperative flare measurements between patients without versus with recurrence among those treated with gas
Evolution of measures of visual acuitypreoperatively and postoperatively at 3 monthsThe best-corrected visual acuity (BCVA) was measured with projected-light Snellen charts and expressed in logMAR.
Evolution of macular statuspreoperatively and postoperatively at 3 monthsEvaluation of macular status with macular imaging by optical coherence tomography (Heidelberg Engineering)
Relapsing status (yes or not)at 3 months postoperativeDetermined by careful fundus and peripheral retina examination.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026