NCT06292572

Brief Summary

To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments

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
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 27, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

February 27, 2024

Last Update Submit

February 27, 2024

Conditions

Keywords

retinal detachmentbilateralvitrectomy

Outcome Measures

Primary Outcomes (1)

  • Rate of surgical success

    Rate of succesful surgical repair of RD within the follow-up period

    6 month after surgery

Secondary Outcomes (1)

  • Visual Acuity

    6 month after surgery

Study Arms (2)

Initial Retinal Detachment

First of both eyes of the same patient that underwent retinal detachment repair

Procedure: Retinal Detachment Surgery

Subsequent Retinal Detachment

Subsequent eye undergoing retinal detachment repair

Procedure: Retinal Detachment Surgery

Interventions

Retinal Detachment Surgery that consists in either Pars Plana Vitrectomy or Scleral Buckling or a combination of both techniques, and with or without use of intraocular tamponade

Also known as: Pars plana Vitrectomy (PPV), Scleral Buckle (SB), PPV + SB
Initial Retinal DetachmentSubsequent Retinal Detachment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that underwent retinal detachment repair surgery for bilateral sequentiel retinal detachment between January 2016 and December 2023 at the Nancy Regional and University Hospital Center

You may qualify if:

  • All patients that underwent retinal detachment repair surgery for bilateral sequential retinal detachment between January 2016 and December 2023 at the Nancy Regional and University Hospital Center (via pars plana vitrectomy or scleral buckling) and with a minimum of 6 month of post-operative follow-up after the last surgery.

You may not qualify if:

  • Patients that underwent surgery at another facility
  • Patients with a history of previous vitrectomy or
  • Patients with a history of trauma from a penetrating injury or ruptured globe, retinal neovascular condition, hereditary vitreo-retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

Location

Related Publications (5)

  • Xu D, Belin PJ, Staropoli PC, Yannuzzi NA, Vangipuram G, Chiang A, Shah GK, Townsend JH, Ryan EH, Klufas MA. Clinical Outcomes in Sequential, Bilateral Rhegmatogenous Retinal Detachment: A Multicenter, Paired-Eye Analysis. Ophthalmol Retina. 2021 Aug;5(8):797-804. doi: 10.1016/j.oret.2020.11.002. Epub 2020 Nov 14.

    PMID: 33197679BACKGROUND
  • Walia HS, Shah GK, Blinder KJ. Characteristics and outcomes of sequential rhegmatogenous retinal detachments. Ophthalmic Surg Lasers Imaging Retina. 2015 Apr;46(4):445-9. doi: 10.3928/23258160-20150422-07.

    PMID: 25970865BACKGROUND
  • Mitry D, Singh J, Yorston D, Siddiqui MA, Murphy AL, Wright AF, Fleck BW, Campbell H, Charteris DG. The fellow eye in retinal detachment: findings from the Scottish Retinal Detachment Study. Br J Ophthalmol. 2012 Jan;96(1):110-3. doi: 10.1136/bjo.2010.194852. Epub 2011 Mar 3.

    PMID: 21378003BACKGROUND
  • Radeck V, Schindler F, Helbig H, Gamulescu MA, Cvetkov Y, Barth T, Maerker D. Characteristics of Bilateral Retinal Detachment. Ophthalmologica. 2023;246(2):99-106. doi: 10.1159/000527625. Epub 2022 Oct 25.

    PMID: 36282053BACKGROUND
  • Mastropasqua L, Carpineto P, Ciancaglini M, Falconio G, Gallenga PE. Treatment of retinal tears and lattice degenerations in fellow eyes in high risk patients suffering retinal detachment: a prospective study. Br J Ophthalmol. 1999 Sep;83(9):1046-9. doi: 10.1136/bjo.83.9.1046.

    PMID: 10460773BACKGROUND

MeSH Terms

Conditions

Retinal Detachment

Interventions

Scleral BucklingPredictive Value of Tests

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeSensitivity and SpecificityEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Baptiste Conart, MD, PhD

    CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Baptiste Conart, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 5, 2024

Study Start

March 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

March 5, 2024

Record last verified: 2024-02

Locations