Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

NCT04557527 | Completed

• 1 other identifier: 283518
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Retinal Detachment With Break

Keywords

retinal detachment; vitrectomy; gas tamponnade; suprachoroidal buckle; viscobuckle; postoperative recovery

Outcome Measures

Primary Outcomes (2)

• 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

  2 years

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

  feasibility trial

  2 years

Study Arms (2)

control

OTHER

Pars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade.

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

treatment

ACTIVE COMPARATOR

Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.

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

Interventions

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

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

control

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 .

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Norfolk and Norwich University Trust Foundation: collaborator
• St Thomas' Hospital, London: collaborator
• University of Sunderland: collaborator
• Moorfields Eye Hospital NHS Foundation Trust: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (6)

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

London, London, SE1 7EH, United Kingdom

Location

Sunderland Eye Infimary

Sunderland, Tyne and Wear, SR2 9HP, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Norfolk and Norwich University Foundation Trust

Norwich, NR47UY, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Southend, SS0 0RY, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 28376555 BACKGROUND

• 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.

  PMID: 27482642 BACKGROUND

• 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.

  PMID: 27853956 BACKGROUND

• 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.

  PMID: 22257789 BACKGROUND

• 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.

  PMID: 23978624 BACKGROUND

• 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.

  PMID: 3808600 BACKGROUND

• 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.

  PMID: 27478632 BACKGROUND

MeSH Terms

Conditions

Retinal Detachment

Interventions

Lasers

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomisation software
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient will be recruited into

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 21, 2020
• Study Start: February 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

GB (6)