Comparative Study Between Three Different Techniques in Drainage of SRF During PPV in RRD

March 20, 2024 updated by: Dina tarek mohamed kamel, Ain Shams University

Comparative Study Between Three Different Techniques in Drainage of Sub-Retinal Fluid During Pars Plana Vitrectomy for Patients With Macula Off Rhegmatogenous Retinal Detachment

The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent sub-retnal fluid and related intra or postoperative complications

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rhegmatogenous retinal detachment (RRD) is a serious surgical condition with significant ocular morbidity if not managed properly. Approaches to the repair of RRD have greatly evolved over the years, leading to outstanding primary surgical success rates. The management of RRD is often a topic of great debate. Several factors may affect surgical success and dictate a surgeon's preference for the technique employed.

Scleral buckling, vitrectomy and pneumatic retinopexy have been used successfully for the treatment of RRD.

Using original breaks to drain subretinal fluid without perfluorocarbon liquid in cases of vitrectomy for RRD may be an effective and safe surgical technique for functional and anatomical recovery without serious complications. but it may leave some SRF at the macula (2) Posterior drainage retinotomy is a surgical technique that involves the creation of a small retinal hole to facilitate the removal of subretinal fluid (SRF), in conjunction with pars plana vitrectomy (PPV), for the treatment of rhegmatogenous retinal detachment (RRD) (3). First described by Machemer in 1981 as a technique for relaxing the retina in proliferative vitreoretinopathy (PVR) and trauma (4), retinotomy has since expanded to include more indications for its use (5). In addition, the use of drainage retinotomy aids the management of bullous RRD, because the complete drainage of fluid significantly decreases the likelihood of retinal fold formation (6). Although there are benefits with retinotomy, complications associated with its use include visual field scotomas and PVR at the endodrainage retinotomy sites .

Perfluorocarbon liquid (PFC) has been a major milestone in vitrectomy surgery and is an invaluable tool in the repair of giant retinal tear-associated detachments (8). By stabilizing the mobile, detached retina, PFC reduces the risk of iatrogenic breaks, especially towards the periphery. PFC may also be useful to assist with subretinal fluid drainage in cases when the retinal break is anterior in order to avoid the need for a posterior drainage retinotomy.

Subretinal fluid that persists after pars plana vitrectomy for RRD is defined by being persistent for more than one month. While mostly benign, SRF has been shown to exhibit complications. Those include the development of macular hole (MH), permanent disruption of the outer retinal layers, subretinal fibrosis, macular edema, and epiretinal membranes affecting the visual outcome.

To the best of our knowledge, very limited reports studied the comparison between the three techniques in an anatomical along with a functional way, presence of subretinal fluid that persists after (PPV) for macula off RRD, or related intra and postoperative complications and also relating them to the functional outcome.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

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

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

Description

Inclusion Criteria:

  • • Age: above 18 years old

    • Patients with rhegmatogenous retinal detachment (RRD) where the detachment is involving the macula.
    • Patients with proliferative vitreoretinopathy (PVR) no more than PVR -B.
    • Patients with peripheral break.
    • Duration of detachment: within one month.

Exclusion Criteria:

  • • Patients with macula on RRD.

    • Patients with tractional retinal detachment.
    • Patients with giant retinal tear.
    • Patients with proliferative vitreoretinopathy (PVR) more than PVR -B.
    • More than one month duration of detachment.
    • Patients with posterior staphyloma.
    • Patients with recurrent retinal detachment.
    • Patients with full thickness macular hole.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
drainage of sub-retinal fluid from the original (primary) break
Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid
Drainage of subretinal fluid during Pars Plana Vitrectomy in patients with rhegmatogenous retinal detachment (RRD)
Active Comparator: Group 2
drainage of sub-retinal fluid using perfluorocarbon (PFC) and removing sub-retinal fluid through the original break or peripheral retinotomy
Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid
Drainage of subretinal fluid during Pars Plana Vitrectomy in patients with rhegmatogenous retinal detachment (RRD)
Active Comparator: Group 3
drainage of sub-retinal fluid through formation of a posterior drainage retinotomy only.
Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid
Drainage of subretinal fluid during Pars Plana Vitrectomy in patients with rhegmatogenous retinal detachment (RRD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV)
Time Frame: within 1 week and within 1 month from the PPV
optical coherence tomography (OCT) imaging after PPV
within 1 week and within 1 month from the PPV

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Dina T Mohamed, master's, Ainshams university
  • Study Chair: Tamer F Elewa, MD, Ainshams university

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)

April 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF drainage techniques in RRD

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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