Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

Study Overview
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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.

Official Title
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Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment: A Randomized, Controlled, Feasibility Trial

Conditions
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Retinal Detachment With Break

Intervention / Treatment
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* Procedure: Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade
* Device: Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient will be recruited into
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control<br>Pars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade. | Procedure: Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade<br>* 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<br>|
| Active Comparator: treatment<br>Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle. | Device: Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal detachment, vitrectomy, gas tamponnade, suprachoroidal buckle, viscobuckle, postoperative recovery