Clinical trial NCT05069675: Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment
Official title: Incidence and Risk Factors for Cystoid Macular Edema After Primary Vitrectomy With Gas Tamponade for Rhegmatogenous Retinal Detachment: a National Study Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystoid Macular Edema
Keywords: cystoid macular edema
rhegmatogenous retinal detachment
vitrectomy
gas tamponade
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of cystoid macular edema
timeFrame: from 1 month up to 6 months after surgery
Secondary outcomes:
measure: factors related to development of macular edema
timeFrame: from 1 month up to 6 months after surgery
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Eye Clinic, University of Bari
city: Bergamo
country: Italy
facility: Eye Clinic, Humanitas University
city: Catania
country: Italy
facility: Eye Clinic, Azienda Policlinico San Marco
city: Palermo
country: Italy
facility: Eye Clinic, University of Palermo
city: Perugia
country: Italy
facility: Eye Clinic, University of Perugia
city: Turin
country: Italy
facility: Eye Clinic University of Turin
Study officials:
References:
citation: Chatziralli I, Theodossiadis G, Dimitriou E, Kazantzis D, Theodossiadis P. Macular Edema after Successful Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment: Factors Affecting Edema Development and Considerations for Treatment. Ocul Immunol Inflamm. 2021 Jan 2;29(1):187-192. doi: 10.1080/09273948.2019.1652330. Epub 2019 Oct 2.
citation: Banker TP, Reilly GS, Jalaj S, Weichel ED. Epiretinal membrane and cystoid macular edema after retinal detachment repair with small-gauge pars plana vitrectomy. Eur J Ophthalmol. 2015 Nov-Dec;25(6):565-70. doi: 10.5301/ejo.5000609. Epub 2015 Apr 15.
citation: Joseph DP, Ryan EH, Ryan CM, Forbes NJK, Wagley S, Yonekawa Y, Mittra RA, Parke DW, Emerson GG, Shah GK, Blinder KJ, Capone A, Williams GA, Eliott D, Gupta OP, Hsu J, Regillo CD. Primary Retinal Detachment Outcomes Study: Pseudophakic Retinal Detachment Outcomes: Primary Retinal Detachment Outcomes Study Report Number 3. Ophthalmology. 2020 Nov;127(11):1507-1514. doi: 10.1016/j.ophtha.2020.05.005. Epub 2020 May 8.