New surgical method for treating retinal detachment
Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment: A Randomized, Controlled, Feasibility Trial
NA · King's College Hospital NHS Trust · NCT04557527
This study is testing a new surgical method for retinal detachment that uses a special gel instead of gas to see if it works better than traditional techniques.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust (other) |
| Locations | 6 sites (Sunderland, Tyne And Wear and 5 other locations) |
| Trial ID | NCT04557527 on ClinicalTrials.gov |
What this trial studies
This study compares traditional surgical techniques for retinal detachment, which typically involve vitrectomy, cryotherapy, and gas tamponade, with a novel approach that uses a suprachoroidal injection of viscoelastic material instead of gas. Eligible patients will be randomly assigned to either the standard treatment group or the new viscobuckle technique group. The goal is to evaluate the effectiveness and safety of this new method in treating retinal detachment caused by one or more breaks. The study aims to provide insights into whether this innovative approach can improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients requiring vitrectomy for primary rhegmatogenous retinal detachment caused by a single or multiple breaks within one clock hour.
Not a fit: Patients with hypersensitivity to hyaluronate, bleeding disorders, or those participating in another interventional study may not benefit from this study.
Why it matters
Potential benefit: If successful, this new surgical method could lead to better recovery rates and fewer complications for patients with retinal detachment.
How similar studies have performed: While traditional methods have been well-established, this specific approach using suprachoroidal visco-buckling is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sunderland, Tyne And Wear and 5 other locations
- Sunderland Eye Infimary — Sunderland, Tyne And Wear, United Kingdom (NOT_YET_RECRUITING)
- Moorfields Eye Hospital — London, United Kingdom (NOT_YET_RECRUITING)
- Guy's & St. Thomas' Hospital NHS Foundatrion Trust — London, United Kingdom (NOT_YET_RECRUITING)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (RECRUITING)
- Norfolk and Norwich University Foundation Trust — Norwich, United Kingdom (NOT_YET_RECRUITING)
- Southend University Hospital NHS Foundation Trust — Southend, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Riti Desai
- Email: ritidesai@nhs.net
- Phone: 020 3299 1297
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retinal Detachment With Break, retinal detachment, vitrectomy, gas tamponnade, suprachoroidal buckle, viscobuckle, postoperative recovery