NCT05069675

Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

Incidence and Risk Factors for Cystoid Macular Edema After Primary Vitrectomy With Gas Tamponade for Rhegmatogenous Retinal Detachment: a National Study Group

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University of Catania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystoid Macular Edema

Interventions

Type	Name	Description
PROCEDURE	vitrectomy	vitrectomy with gas tamponade

Timeline

• Start date: 2021-07-12
• Primary completion: 2022-10-01
• Completion: 2023-01-01
• First posted: 2021-10-06
• Last updated: 2022-05-25

Locations

6 sites across 1 country: Italy