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

C

Central Hospital, Nancy, France

Status

Completed

Conditions

Retinal Detachment

Treatments

Other: Aqueous flare measurement

Study type

Observational

Funder types

Other

Identifiers

NCT05053698
2020PI209

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

48 participants in 4 patient groups

Initial gas tamponade
Description:
Primary vitrectomy and fluid-air exchange with SF6 or C2F6 gas tamponade
Treatment:
Other: Aqueous flare measurement
Initial silicone oil tamponade
Description:
Primary vitrectomy and fluid-air exchange with silicone oil tamponade
Treatment:
Other: Aqueous flare measurement
Relapse treated with gas tamponade
Description:
Secondary vitrectomy and fluid-air exchange with SF6 or C2F6 or C3F8 gas tamponade
Treatment:
Other: Aqueous flare measurement
Relapse treated with silicone oil tamponade
Description:
Secondary vitrectomy and fluid-air exchange with silicone oil tamponade
Treatment:
Other: Aqueous flare measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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