Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

NCT ID: NCT04557527

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Retinal Detachment With Break

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient will be recruited into
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

randomisation software

Study Groups

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control

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

Group Type OTHER

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

Intervention Type 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

treatment

Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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 .

Interventions

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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

Intervention Type PROCEDURE

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 .

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norfolk and Norwich University Trust Foundation

UNKNOWN

Sponsor Role collaborator

St Thomas' Hospital, London

OTHER

Sponsor Role collaborator

University of Sunderland

OTHER

Sponsor Role collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

London, London, United Kingdom

Site Status

Sunderland Eye Infimary

Sunderland, Tyne and Wear, United Kingdom

Site Status

Moorfields Eye Hospital

London, , United Kingdom

Site Status

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

Norfolk and Norwich University Foundation Trust

Norwich, , United Kingdom

Site Status

Southend University Hospital NHS Foundation Trust

Southend, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 28376555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27482642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27853956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22257789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23978624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3808600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27478632 (View on PubMed)

Other Identifiers

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283518

Identifier Type: -

Identifier Source: org_study_id

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