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Retinal Detachment With BreakVIKINGNCT04557527

Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

A study testing Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade and Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device) in people with Retinal Detachment With Break, run by King's College Hospital NHS Trust at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Detachment With Break
What is being tested?
Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade and Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
6 sitesUnited Kingdom
Study dates
7 Feb 2022to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 15Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

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

    London, London, SE1 7EH

  • Moorfields Eye Hospital

    London, EC1V 2PD

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

  • Norfolk and Norwich University Foundation Trust

    Norwich, NR47UY

  • Southend University Hospital NHS Foundation Trust

    Southend, SS0 0RY

  • Sunderland Eye Infimary

    Sunderland, Tyne and Wear, SR2 9HP

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade, Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)
Keywords
retinal detachment, vitrectomy, gas tamponnade, suprachoroidal buckle, viscobuckle, postoperative recovery
Medical subject headings
Retinal Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponadeProcedure or surgery

    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

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

Study groups in NCT04557527
Study groupRoleWhat they receive
controlOtherPars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade.
Receives: Procedure: Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade
treatmentActive comparatorPars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.
Receives: Device: Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    feasibility trial

    Measured: 2 years

  2. To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle.

    feasibility trial

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2020
  2. Study start7 Feb 2022
  3. Primary completion31 Dec 2024
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patient will be recruited into
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04557527
Sponsor's protocol ID
283518
Acronym
VIKING
Status last verified
Aug 2025
First submitted
9 Sep 2020
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Boden KT, Januschowski K, Szurman P. [Suprachoroidal Hydrogel Buckle - a New Minimal-Invasive Technique in Treatment of Rhegmatogenous Retinal Detachment]. Klin Monbl Augenheilkd. 2019 Mar;236(3):308-312. doi: 10.1055/s-0043-102947. Epub 2017 Apr 4. German.

    PubMed 28376555

  • El Rayes EN, Mikhail M, El Cheweiky H, Elsawah K, Maia A. SUPRACHOROIDAL BUCKLING FOR THE MANAGEMENT OF RHEGMATOGENOUS RETINAL DETACHMENTS SECONDARY TO PERIPHERAL RETINAL BREAKS. Retina. 2017 Apr;37(4):622-629. doi: 10.1097/IAE.0000000000001214.

    PubMed 27482642

  • Mikhail M, El-Rayes EN, Kojima K, Ajlan R, Rezende F. Catheter-guided suprachoroidal buckling of rhegmatogenous retinal detachments secondary to peripheral retinal breaks. Graefes Arch Clin Exp Ophthalmol. 2017 Jan;255(1):17-23. doi: 10.1007/s00417-016-3530-8. Epub 2016 Nov 16.

    PubMed 27853956

  • Mitry D, Awan MA, Borooah S, Siddiqui MA, Brogan K, Fleck BW, Wright A, Campbell H, Singh J, Charteris DG, Yorston D. Surgical outcome and risk stratification for primary retinal detachment repair: results from the Scottish Retinal Detachment study. Br J Ophthalmol. 2012 May;96(5):730-4. doi: 10.1136/bjophthalmol-2011-300581. Epub 2012 Jan 18.

    PubMed 22257789

  • Jackson TL, Donachie PH, Sallam A, Sparrow JM, Johnston RL. United Kingdom National Ophthalmology Database study of vitreoretinal surgery: report 3, retinal detachment. Ophthalmology. 2014 Mar;121(3):643-8. doi: 10.1016/j.ophtha.2013.07.015. Epub 2013 Aug 23.

    PubMed 23978624

  • Poole TA, Sudarsky RD. Suprachoroidal implantation for the treatment of retinal detachment. Ophthalmology. 1986 Nov;93(11):1408-12. doi: 10.1016/s0161-6420(86)33553-x.

    PubMed 3808600

  • Mohamed YH, Ono K, Kinoshita H, Uematsu M, Tsuiki E, Fujikawa A, Kitaoka T. Success Rates of Vitrectomy in Treatment of Rhegmatogenous Retinal Detachment. J Ophthalmol. 2016;2016:2193518. doi: 10.1155/2016/2193518. Epub 2016 Jul 13.

    PubMed 27478632

  • Saidkasimova S, Lee CN, Murphy GSP, Jackson TL; VIKING study group. Suprachoroidal VIsco-bucKlING versus gas tamponade for the treatment of rhegmatogenous retinal detachment (VIKING): study protocol for a multi-centre, randomised, controlled feasibility study. Pilot Feasibility Stud. 2026 Mar 17;12(1):78. doi: 10.1186/s40814-026-01787-w.

    PubMed 41845462

Questions about this trial

What is this clinical trial studying?

A study testing Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade and Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device) in people with Retinal Detachment With Break, run by King's College Hospital NHS Trust at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04557527, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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