NCT05069675

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

September 20, 2021

Last Update Submit

May 18, 2022

Conditions

Cystoid Macular Edema

Keywords

cystoid macular edemarhegmatogenous retinal detachmentvitrectomygas tamponade

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • factors related to development of macular edema

    from 1 month up to 6 months after surgery

Interventions

vitrectomyPROCEDURE

vitrectomy with gas tamponade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Eye Clinic, University of Bari

Bari, Italy

RECRUITING

Eye Clinic, Humanitas University

Bergamo, Italy

RECRUITING

Eye Clinic, Azienda Policlinico San Marco

Catania, 95123, Italy

RECRUITING

Eye Clinic, University of Palermo

Palermo, Italy

RECRUITING

Eye Clinic, University of Perugia

Perugia, Italy

RECRUITING

Eye Clinic University of Turin

Turin, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31577459BACKGROUND

  • 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.

    PMID: 25907288BACKGROUND

  • 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.

    PMID: 32437865BACKGROUND

MeSH Terms

Conditions

Macular Edema

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Antonio Longo, MD, PhD

CONTACT

+393460131548antlongo@unict.it

Matteo R Fallico, MD, PhD

CONTACT

matteofallico@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 6, 2021

Study Start

July 12, 2021

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(6)