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

Retinal Detachment Clinical Trial

— FLADESIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053698
• Other study ID #: 2020PI209
• Status: Completed
• Start date: June 3, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: September 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

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).

Locations

Country	Name	City	State
France	BERROD Jean-Paul MD	Nancy	Grand EST

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Evolution of macular status	Evaluation of macular status with macular imaging by optical coherence tomography (Heidelberg Engineering)	preoperatively and postoperatively at 3 months
Secondary	Relapsing status (yes or not)	Determined by careful fundus and peripheral retina examination.	at 3 months postoperative