Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment
NCT ID: NCT04557527
Last Updated: 2025-08-06
Study Results
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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COMPLETED
NA
36 participants
INTERVENTIONAL
2022-02-07
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control
Pars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade.
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
treatment
Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.
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 .
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
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 .
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Norfolk and Norwich University Trust Foundation
UNKNOWN
St Thomas' Hospital, London
OTHER
University of Sunderland
OTHER
Moorfields Eye Hospital NHS Foundation Trust
OTHER
Mid and South Essex NHS Foundation Trust
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
King's College Hospital NHS Trust
OTHER
Responsible Party
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Locations
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Guy's & St. Thomas' Hospital NHS Foundatrion Trust
London, London, United Kingdom
Sunderland Eye Infimary
Sunderland, Tyne and Wear, United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Norfolk and Norwich University Foundation Trust
Norwich, , United Kingdom
Southend University Hospital NHS Foundation Trust
Southend, , United Kingdom
Countries
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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283518
Identifier Type: -
Identifier Source: org_study_id
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