Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment (VIKING)

King's College Hospital NHS Trust

Status: Enrolling

Conditions: Retinal Detachment With Break

Treatments: 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT04557527

283518

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

control

Other group

Description:

Pars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade.

Treatment:

Procedure: Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade

treatment

Active Comparator group

Description:

Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.

Treatment:

Device: Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)