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Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

U

University of Catania

Status

Unknown

Conditions

Cystoid Macular Edema

Treatments

Procedure: vitrectomy

Study type

Observational

Funder types

Other

Identifiers

NCT05069675
69/2021/PO

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 after hospitalization 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 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

Trial contacts and locations

6

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Central trial contact

Matteo R Fallico, MD, PhD; Antonio Longo, MD, PhD

Data sourced from clinicaltrials.gov

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