Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment

NCT ID: NCT05069675

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-12

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Cystoid Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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vitrectomy

vitrectomy with gas tamponade

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Antonio Longo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye Clinic, University of Bari

Bari, , Italy

Site Status RECRUITING

Eye Clinic, Humanitas University

Bergamo, , Italy

Site Status RECRUITING

Eye Clinic, Azienda Policlinico San Marco

Catania, , Italy

Site Status RECRUITING

Eye Clinic, University of Palermo

Palermo, , Italy

Site Status RECRUITING

Eye Clinic, University of Perugia

Perugia, , Italy

Site Status RECRUITING

Eye Clinic University of Turin

Turin, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Longo, MD, PhD

Role: CONTACT

+393460131548

Matteo R Fallico, MD, PhD

Role: CONTACT

Facility Contacts

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Francesco Boscia, MD

Role: primary

Mario Romano, MD, PhD

Role: primary

Antonio Longo, MD PhD

Role: primary

Vincenza Bonfiglio, MD, PhD

Role: primary

Marco Lupidi, MD

Role: primary

Michele Reibaldi, MD PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31577459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25907288 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32437865 (View on PubMed)

Other Identifiers

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69/2021/PO

Identifier Type: -

Identifier Source: org_study_id

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