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Completed

NCT Number: NCT05053698

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

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

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BERROD Jean-Paul MD

Nancy, Grand Est, 54000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aqueous flare measurement

Other

Aqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan).

Primary outcomes

  1. Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter)

    Time frame: 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 outcomes

  1. Change in aqueous flare measurement (measured with a laser flare-cell meter)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: at 3 months postoperative

    Determined by careful fundus and peripheral retina examination.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: FLADESIL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2021
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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