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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05069675
Enrollment
2000
Registered
2021-10-06
Start date
2021-07-12
Completion date
2023-01-31
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystoid Macular Edema

Keywords

cystoid macular edema, rhegmatogenous retinal detachment, vitrectomy, gas tamponade

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.

Interventions

PROCEDUREvitrectomy

vitrectomy with gas tamponade

Sponsors

University of Catania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
factors related to development of macular edemafrom 1 month up to 6 months after surgerydemographics, systemic and ocular parameters

Countries

Italy

Contacts

Primary ContactAntonio Longo, MD, PhD
antlongo@unict.it+393460131548
Backup ContactMatteo R Fallico, MD, PhD
matteofallico@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026