Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

Cystoid Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069675
• Other study ID #: 69/2021/PO
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: January 2023

Study information

• Verified date: May 2022
• Source: University of Catania
• Contact: Antonio Longo, MD, PhD
• Phone: +393460131548
• Email: antlongo[@]unict.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystoid Macular Edema
• Edema
• Macular Edema
• Retinal Detachment

Intervention

Procedure:
• vitrectomy
vitrectomy with gas tamponade

Locations

Country	Name	City	State
Italy	Eye Clinic, University of Bari	Bari
Italy	Eye Clinic, Humanitas University	Bergamo
Italy	Eye Clinic, Azienda Policlinico San Marco	Catania
Italy	Eye Clinic, University of Palermo	Palermo
Italy	Eye Clinic, University of Perugia	Perugia
Italy	Eye Clinic University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of cystoid macular edema	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	factors related to development of macular edema	demographics, systemic and ocular parameters	from 1 month up to 6 months after surgery