Retinal Detachment With Break
Conditions
Keywords
retinal detachment, vitrectomy, gas tamponnade, suprachoroidal buckle, viscobuckle, postoperative recovery
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.
Interventions
PROCEDUREPars 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
DEVICESuprachoroidal 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 .
Sponsors
Norfolk and Norwich University Trust Foundation
St Thomas' Hospital, London
University of Sunderland
Moorfields Eye Hospital NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
King's College Hospital NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
randomisation software
Intervention model description
Patient will be recruited into
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 2 years | feasibility trial |
| To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle. | 2 years | feasibility trial |
Countries
United Kingdom
Outcome results
None listed