Phase
Condition
Macular Degeneration
Retina
Mood Disorders
Treatment
Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade
Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients requiring pars plana vitrectomy for the treatment of primary rhegmatogenousretinal 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
Exclusion Criteria:
- Hypersensitivity to hyaluronate or. HEALON5® PRO OVD
- Participation in another interventional study within 8 weeks of enrolment or plannedto occur during this study.
- Bleeding disorders or the use of anticoagulants (such as warfarin, rivaroxaban) ordual anti-platelet drugs such as aspirin with clopidogrel. Monotherapy with low dose (≤100 mg) aspirin is permitted, and if clinically appropriate this should be stoppedprior 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 ofthe trial.
- Any other condition that, in the opinion of the investigator, would prevent theparticipant from granting informed consent or complying with the protocol, such asdementia, 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 opinionof the attending vitreoretinal surgeon, would preclude the safe delivery of Healon 5into the suprachoroidal space (detail the specific reason for exclusion in the sourcedocuments)
- Presence of other ocular co-morbidity that, in the opinion of the investigator, islikely to prevent an accurate assessment of retinal attachment
- Current intraocular inflammation other than mild cellular activity thought to besecondary to RD
- Current ocular or periocular infection other than blepharitis
Study Design
Study Description
Connect with a study center
Sunderland Eye Infimary
Sunderland, Tyne And Wear SR2 9HP
United KingdomSite Not Available
Guy's & St. Thomas' Hospital NHS Foundatrion Trust
London, SE1 7EH
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomActive - Recruiting
Moorfields Eye Hospital
London, EC1V 2PD
United KingdomSite Not Available
Norfolk and Norwich University Foundation Trust
Norwich, NR47UY
United KingdomSite Not Available
Southend University Hospital NHS Foundation Trust
Southend, SS0 0RY
United KingdomSite Not Available
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