Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

Last updated: July 3, 2023
Sponsor: King's College Hospital NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Retina

Mood Disorders

Treatment

Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade

Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)

Clinical Study ID

NCT04557527
283518
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients requiring pars plana vitrectomy for the treatment of primary rhegmatogenousretinal 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

Exclusion Criteria:

  • Hypersensitivity to hyaluronate or. HEALON5® PRO OVD
  • Participation in another interventional study within 8 weeks of enrolment or plannedto occur during this study.
  • Bleeding disorders or the use of anticoagulants (such as warfarin, rivaroxaban) ordual anti-platelet drugs such as aspirin with clopidogrel. Monotherapy with low dose (≤100 mg) aspirin is permitted, and if clinically appropriate this should be stoppedprior 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 ofthe trial.
  • Any other condition that, in the opinion of the investigator, would prevent theparticipant from granting informed consent or complying with the protocol, such asdementia, 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 opinionof the attending vitreoretinal surgeon, would preclude the safe delivery of Healon 5into the suprachoroidal space (detail the specific reason for exclusion in the sourcedocuments)
  • Presence of other ocular co-morbidity that, in the opinion of the investigator, islikely to prevent an accurate assessment of retinal attachment
  • Current intraocular inflammation other than mild cellular activity thought to besecondary to RD
  • Current ocular or periocular infection other than blepharitis

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade
Phase:
Study Start date:
February 07, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Sunderland Eye Infimary

    Sunderland, Tyne And Wear SR2 9HP
    United Kingdom

    Site Not Available

  • Guy's & St. Thomas' Hospital NHS Foundatrion Trust

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Moorfields Eye Hospital

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Foundation Trust

    Norwich, NR47UY
    United Kingdom

    Site Not Available

  • Southend University Hospital NHS Foundation Trust

    Southend, SS0 0RY
    United Kingdom

    Site Not Available

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