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

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT05053698
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment	Other: Aqueous flare measurement

Study Design

• Study Type: Observational
• Actual Enrollment: 48 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.
• Actual Study Start Date: Jun 3, 2020
• Actual Primary Completion Date: Jun 4, 2021
• Actual Study Completion Date: Jun 4, 2021

Arms and Interventions

Arm	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).

Outcome Measures

Primary Outcome Measures

1. 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 surgery]

   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

Secondary Outcome Measures

1. Change in aqueous flare measurement (measured with a laser flare-cell meter) [postoperatively at 2 weeks and 3 months after surgery]

   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.

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

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

3. Evolution of measures of visual acuity [preoperatively and postoperatively at 3 months]

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

4. Evolution of macular status [preoperatively and postoperatively at 3 months]

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

5. Relapsing status (yes or not) [at 3 months postoperative]

   Determined by careful fundus and peripheral retina examination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BERROD Jean-Paul MD	Nancy	Grand EST	France	54000

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BERROD Jean-Paul, Professor BERROD Jean-Paul, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05053698
• Other Study ID Numbers: 2020PI209
• First Posted: Sep 22, 2021
• Last Update Posted: Sep 22, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by BERROD Jean-Paul, Professor BERROD Jean-Paul, Central Hospital, Nancy, France: Aqueous Flare; Retinal Detachment
• Additional relevant MeSH terms: Retinal Detachment; Dissociative Disorders

Study Results

No Results Posted as of Sep 22, 2021