Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

May 18, 2022 updated by: Antonio Longo, University of Catania

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy
        • Recruiting
        • Eye Clinic, University of Bari
        • Contact:
          • Francesco Boscia, MD
      • Bergamo, Italy
        • Recruiting
        • Eye Clinic, Humanitas University
        • Contact:
          • Mario Romano, MD, PhD
      • Catania, Italy, 95123
        • Recruiting
        • Eye Clinic, Azienda Policlinico San Marco
        • Contact:
      • Palermo, Italy
      • Perugia, Italy
        • Recruiting
        • Eye Clinic, University of Perugia
        • Contact:
          • Marco Lupidi, MD
      • Turin, Italy
        • Recruiting
        • Eye Clinic University of Turin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

consecutive patients with primary regmatogenous retinal detechment successfully treated by vitrectomy with gas tamnponade at several Eye Centers, will be included in the study.

clinical data will be retrospectively retrieved.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of cystoid macular edema
Time Frame: 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
from 1 month up to 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
factors related to development of macular edema
Time Frame: from 1 month up to 6 months after surgery
demographics, systemic and ocular parameters
from 1 month up to 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69/2021/PO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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