Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

Last updated: May 18, 2022
Sponsor: University of Catania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Edema

Cystoid Macular Edema

Retina

Treatment

N/A

Clinical Study ID

NCT05069675
69/2021/PO
  • Ages > 18
  • All Genders

Study Summary

To investigate the incidence of cystoid macular edema in eyes with primary rhegmatogenous retinal detachment successfully treated with vitrectomy with gas tamponade, and to evaluate the clinical variables associated with its development.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • primary rhegmatogenous retinal detachment treated with vitrectomy with gas tamponade;
  • follow-up of 3 months or more;
  • age > 18 years ;
  • no previous eye surgery, except cataract surgery performed at least 6 months afterhospitalization for retinal detachment;
  • anatomical success, i.e. retinal re-attachment, after a single gas vitrectomy;
  • no other eye surgery during follow-up;
  • availability of optical coherence tomography (OCT) imaging

Exclusion

Exclusion Criteria:

  • history of other eye diseases (glaucoma, age-related macular degeneration, uveitis,diabetic retinopathy, maculopathy);
  • macular hole;
  • recurrent retinal detachment;
  • use of silicone oil is used as a tamponading agent

Study Design

Total Participants: 2000
Study Start date:
July 12, 2021
Estimated Completion Date:
January 31, 2023

Study Description

this is an observational, retrospective, multicentre study. The study is based on the retrospective collection of clinical data from patients undergoing gas tamponade vitrectomy for rhegmatogenous retinal detachment. The collection of such data by the investigators will take place at each participating center anonymously.

demographics, systemic, and preoperative, intraoperative and post-operative data will be collected The sample size was calculated to obtain approximately 200 patients with cystoid macular edema. Since cystoid macular edema has been detected in 13% of patients after retinal detachment gas vitrectomy, and assuming that this event can occur between 10% and 15% of cases, the study will include at least 2000 cases.

Connect with a study center

  • Eye Clinic, University of Bari

    Bari,
    Italy

    Active - Recruiting

  • Eye Clinic, Humanitas University

    Bergamo,
    Italy

    Active - Recruiting

  • Eye Clinic, Azienda Policlinico San Marco

    Catania, 95123
    Italy

    Active - Recruiting

  • Eye Clinic, University of Palermo

    Palermo,
    Italy

    Active - Recruiting

  • Eye Clinic, University of Perugia

    Perugia,
    Italy

    Active - Recruiting

  • Eye Clinic University of Turin

    Turin,
    Italy

    Active - Recruiting

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