Suprachoroidal viscobuckling for retinal detachment (VIKING). Ver 1.0
Research type
Research Study
Full title
Suprachoroidal VIsco-bucKlING for the treatment of rhegmatogenous retinal detachment (VIKING): a randomized, controlled, feasibility trial
IRAS ID
283518
Contact name
Tim Jackson
Contact email
Sponsor organisation
Research Office Kings College Hospital London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
BACKGROUND: This study explores a new way of treating retinal detachment, a potentially blinding condition that requires urgent surgery. Retinal detachment occurs when the light-sensing layer of cells comes away from its usual position lining the inside of the back of the eye. It is caused by a break or hole in the retina. Standard surgery involves multiple steps, including injection of a gas bubble to fill the inside of the eye. Gas is burdensome for patients as they need to position their head in often awkward positions to float the bubble onto the break, and they cannot see through the bubble until it absorbs in 1-2 months. Likewise the surgeon can't see through the gas, so retinal examination is difficult. Gas precludes patients from flying and having some anaesthetics, and may preclude driving. It can cause cataract (opacity of the natural lens of the eye) and high eye pressure.
INTERVENTION: Standard surgery (vitrectomy) but replacing the gas bubble with a 'viscobuckle', created by injecting a liquid gel under the retinal break. The gel supports closure of the break. The new technique ('viscovitrectomy') avoids gas to thereby reduce the burden and duration of patients' recovery, and complications of surgery. The gel (Healon 5) is licensed for use in the eye.
AIM: To determine if a larger study of viscovitrectomy is feasible.PARTICIPANTS: Males and females aged at least 18 years requiring surgery (vitrectomy) for their first retinal detachment. There must be only one break, or multiple breaks clustered closely together (within 1 'clock hour' of the retina). Half the participants will be randomly allocated to standard vitrectomy with gas; half to viscovitrectomy.
SETTING: 5-6 NHS hospitals aiming to recruit 50 participants over one year.
FOLLOW-UP: Day 1 and Weeks 1, 6, 12 and 24, reflecting standard care.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0088
Date of REC Opinion
6 May 2021
REC opinion
Further Information Favourable Opinion