Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
| St Thomas' Hospital, London | OTHER |
| University of Sunderland | OTHER |
| Moorfields Eye Hospital NHS Foundation Trust |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Other | Pars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade. |
|
| treatment | Active Comparator | Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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:
Study eye:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's & St. Thomas' Hospital NHS Foundatrion Trust | London | London | SE1 7EH | United Kingdom | ||
| Sunderland Eye Infimary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28376555 | Background | 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. | |
| 27482642 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Mid and South Essex NHS Foundation Trust | OTHER |
| Sheffield Teaching Hospitals NHS Foundation Trust | OTHER |
Patient will be recruited into
Not provided
Not provided
randomisation software
Not provided
|
| 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 . |
|
| Sunderland |
| Tyne and Wear |
| SR2 9HP |
| United Kingdom |
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Norfolk and Norwich University Foundation Trust | Norwich | NR47UY | United Kingdom |
| Southend University Hospital NHS Foundation Trust | Southend | SS0 0RY | United Kingdom |
| 27853956 | 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. |
| 22257789 | 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. |
| 23978624 | 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. |
| 3808600 | 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. |
| 27478632 | 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. |
| 41845462 | Derived | 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. |
| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided