Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments

February 27, 2024 updated by: Professeur Jean-Baptiste CONART, Central Hospital, Nancy, France
To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Bilateral retinal detachment is a rare but sight-threatening disease, that can cause blindness and poor quality of life.

It has been proved that patients who suffer from RD in one eye have a considerably increased risk to subsequently develop an RD in the fellow eye.

It can be expected that patients who experienced a RD in one eye, tend to present sooner when experiencing a RD in the fellow eye, and thus have a greater visual and/or anatomical prognosis.

In this study, we aim to describe characteristics of bilateral RD and compare the initial and subsequent eye in terms of clinical preoperative features, surgical management, and anatomical and visual results.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Meurthe-et-Moselle
      • Vandoeuvre les nancy, Meurthe-et-Moselle, France, 54511
        • CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initial Retinal Detachment
First of both eyes of the same patient that underwent retinal detachment repair
Procedure: Retinal Detachment Surgery
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
Other Names:
  • Pars plana Vitrectomy (PPV)
  • Scleral Buckle (SB)
  • PPV + SB
Subsequent Retinal Detachment
Subsequent eye undergoing retinal detachment repair
Procedure: Retinal Detachment Surgery
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
Other Names:
  • Pars plana Vitrectomy (PPV)
  • Scleral Buckle (SB)
  • PPV + SB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of surgical success
Time Frame: 6 month after surgery
Rate of succesful surgical repair of RD within the follow-up period
6 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 6 month after surgery
LogMAR Visual acuity measured at the follow-up visit
6 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Jean-Baptiste Conart, MD, PhD, CHRU de Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Estimated)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PI029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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