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

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

Study Overview

• Status: Completed
• Conditions: Retinal Detachment
• Intervention / Treatment: Other: Aqueous flare measurement

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Initial gas tamponade; Primary vitrectomy and fluid-air exchange with SF6 or C2F6 gas tamponade	Other: 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).
Initial silicone oil tamponade; Primary vitrectomy and fluid-air exchange with silicone oil tamponade	Other: 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).
Relapse treated with gas tamponade; Secondary vitrectomy and fluid-air exchange with SF6 or C2F6 or C3F8 gas tamponade	Other: 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).
Relapse treated with silicone oil tamponade; Secondary vitrectomy and fluid-air exchange with silicone oil tamponade	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	To compare the preoperative flare measurements between patients without versus with recurrence among those treated with gas	preoperative
Evolution of measures of visual acuity	The best-corrected visual acuity (BCVA) was measured with projected-light Snellen charts and expressed in logMAR.	preoperatively and postoperatively at 3 months
Evolution of macular status	Evaluation of macular status with macular imaging by optical coherence tomography (Heidelberg Engineering)	preoperatively and postoperatively at 3 months
Relapsing status (yes or not)	Determined by careful fundus and peripheral retina examination.	at 3 months postoperative

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Jean-Paul BERROD, Professor MD, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Retinal Detachment; Aqueous Flare
• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Retinal Detachment; Dissociative Disorders
• Other Study ID Numbers: 2020PI209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No