Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

• Conditions: Cystoid Macular Edema

• Registration Number: NCT05069675
• Lead Sponsor: University of Catania

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25
• Primary Completion: 2022-10
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of cystoid macular edema	from 1 month up to 6 months after surgery	cystoid macular edema assessed by OCT (central subfield thickness \>310 micron, with presence of intraretinal cystic areas of low reflectivity in OPL) visual acuity

Secondary Outcome Measures

Name	Time	Method
factors related to development of macular edema	from 1 month up to 6 months after surgery	demographics, systemic and ocular parameters

Trial Locations

Locations (6)

Eye Clinic, Humanitas University; 🇮🇹 Bergamo, Italy

Eye Clinic, Azienda Policlinico San Marco; 🇮🇹 Catania, Italy

Eye Clinic, University of Bari; 🇮🇹 Bari, Italy

Eye Clinic, University of Palermo; 🇮🇹 Palermo, Italy

Eye Clinic University of Turin; 🇮🇹 Turin, Italy

Eye Clinic, University of Perugia; 🇮🇹 Perugia, Italy