Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment (VIKING)

July 3, 2023 updated by: King's College Hospital NHS Trust

Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment: A Randomized, Controlled, Feasibility Trial

The study compares standard surgery for retinal detachment (RD) (vitrectomy, cryotherapy and gas) with a surgical variation that replaces the intraocular gas tamponade with suprachoroidal injection of viscoelastic underneath the break that caused the retinal detachment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and the potential risks, the eligible patients who have given written consent to the treatment will be randomized into treatment (vitrectomy, cryo and gas) or control (viscobuckle vitrectomy) group.

Study Type

Interventional

Enrollment (Estimated)

50

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

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy L Jackson, PhD,FRCOpht
      • London, United Kingdom, EC1V 2PD
        • Not yet recruiting
        • Moorfields Eye Hospital
        • Contact:
          • Louisa Wickham, FRCophtha
      • London, United Kingdom, SE1 7EH
        • Not yet recruiting
        • Guy's & St. Thomas' Hospital NHS Foundatrion Trust
        • Contact:
          • Alistair Laidlaw, MD, FRCOphth
      • Norwich, United Kingdom, NR47UY
        • Not yet recruiting
        • Norfolk and Norwich University Foundation Trust
        • Contact:
        • Principal Investigator:
          • Shohista Saidkasimova, FRCOphth
      • Southend, United Kingdom, SS0 0RY
        • Not yet recruiting
        • Southend University Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Aman Chandra, FRCOphth
    • Tyne And Wear
      • Sunderland, Tyne And Wear, United Kingdom, SR2 9HP
        • Not yet recruiting
        • Sunderland Eye Infimary
        • Contact:
        • Principal Investigator:
          • David Steel, FRCOphth

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients requiring pars plana vitrectomy for the treatment of primary rhegmatogenous retinal detachment (RD) caused by a single break, or multiple breaks within one clock hour. The final determination of qualifying breaks is made at the time of surgery following 360-degree, internal, indented search using a wide-angle viewing system.

Exclusion Criteria:

  • Hypersensitivity to hyaluronate or. HEALON5® PRO OVD
  • Participation in another interventional study within 8 weeks of enrolment or planned to occur during this study.
  • Bleeding disorders or the use of anticoagulants (such as warfarin, rivaroxaban) or dual anti-platelet drugs such as aspirin with clopidogrel. Monotherapy with low dose (≤100 mg) aspirin is permitted, and if clinically appropriate this should be stopped prior to surgery and recommenced only after satisfactory day 1 post-operative review.
  • Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.
  • Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical disease.

Study eye:

  • Presence of proliferative vitreoretinopathy (PVR) or any tractional RD
  • Previous vitreoretinal surgery, open-globe injury or endophthalmitis
  • Aphakia
  • Previous or current congenital cataract
  • Previous or current suprachoroidal haemorrhage
  • Congenital or acquired ocular, orbital or periocular abnormality that, in the opinion of the attending vitreoretinal surgeon, would preclude the safe delivery of Healon 5 into the suprachoroidal space (detail the specific reason for exclusion in the source documents)
  • Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to prevent an accurate assessment of retinal attachment
  • Current intraocular inflammation other than mild cellular activity thought to be secondary to RD
  • Current ocular or periocular infection other than blepharitis

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
Other: control
Pars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade.
Procedure: Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade
Conventional pars plana vitrectomy procedure is used to treat rhegmatogenous retinal detachment- laser or cryo retinopexy intraocular gas tamponade (SF6, C2F6 or C3F8) are chosen according to the number and size of the causative retinal break(s) and surgeons clinical judgement
Active Comparator: treatment
Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.
Device: Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)
After drainage of subretinal fluid, approximately 0.5 ml of Healon 5 is injected in to the suprachoroidal space underlying the retinal break. Laser retinopexy is applied around the break .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To establish if it is feasible to recruit, retain, and evaluate patients with RD into a larger randomised controlled trial of vitrectomy and suprachoroidal viscobuckle.
Time Frame: 2 years
feasibility trial
2 years
To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle.
Time Frame: 2 years
feasibility trial
2 years

Collaborators and Investigators

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

Sponsor

King's College Hospital NHS Trust

Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust
Moorfields Eye Hospital NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
St Thomas' Hospital, London
Norfolk and Norwich University Trust Foundation
University of Sunderland

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 (Actual)

February 7, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 283518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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