Clinical trial NCT04557527: Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment
Official title: Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment: A Randomized, Controlled, Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinal Detachment With Break
Keywords: retinal detachment
vitrectomy
gas tamponnade
suprachoroidal buckle
viscobuckle
postoperative recovery
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Norfolk and Norwich University Trust Foundation
name: St Thomas' Hospital, London
name: University of Sunderland
name: Moorfields Eye Hospital NHS Foundation Trust
name: Mid and South Essex NHS Foundation Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2020-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will be recruited into
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 2 years
measure: To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infimary
state: Tyne And Wear
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: Guy's & St. Thomas' Hospital NHS Foundatrion Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Foundation Trust
city: Southend
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.