Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

Sponsor

University of Catania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05069675

Collaborator

(none)

2,000

Enrollment

Locations

17.7

Anticipated Duration (Months)

333.3

Patients Per Site

18.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystoid Macular Edema	Procedure: vitrectomy

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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 12, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Eye Clinic, University of Bari	Bari	Italy
2	Eye Clinic, Humanitas University	Bergamo	Italy
3	Eye Clinic, Azienda Policlinico San Marco	Catania	Italy	95123
4	Eye Clinic, University of Palermo	Palermo	Italy
5	Eye Clinic, University of Perugia	Perugia	Italy
6	Eye Clinic University of Turin	Turin	Italy