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

Primary Purpose

Retinal Detachment With Break

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade
Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment With Break focused on measuring retinal detachment, vitrectomy, gas tamponnade, suprachoroidal buckle, viscobuckle, postoperative recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sunderland Eye Infimary
  • Moorfields Eye Hospital
  • Guy's & St. Thomas' Hospital NHS Foundatrion Trust
  • King's College Hospital NHS Foundation TrustRecruiting
  • Norfolk and Norwich University Foundation Trust
  • Southend University Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

control

treatment

Arm Description

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

Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.

Outcomes

Primary Outcome Measures

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
To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle.
feasibility trial

Secondary Outcome Measures

Full Information

First Posted
September 9, 2020
Last Updated
July 3, 2023
Sponsor
King's College Hospital NHS Trust
Collaborators
Norfolk and Norwich University Trust Foundation, St Thomas' Hospital, London, University of Sunderland, Moorfields Eye Hospital NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04557527
Brief Title
Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment
Acronym
VIKING
Official Title
Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment: A Randomized, Controlled, Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
Norfolk and Norwich University Trust Foundation, St Thomas' Hospital, London, University of Sunderland, Moorfields Eye Hospital NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment With Break
Keywords
retinal detachment, vitrectomy, gas tamponnade, suprachoroidal buckle, viscobuckle, postoperative recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient will be recruited into
Masking
None (Open Label)
Masking Description
randomisation software
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Other
Arm Description
Pars plana vitrectomy, retinopexy with laser or cryotherapy, and intravitreal gas tamponade.
Arm Title
treatment
Arm Type
Active Comparator
Arm Description
Pars plana vitrectomy, laser retinopexy, suprachoroidal viscobuckle.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)
Intervention Description
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 .
Primary Outcome Measure Information:
Title
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.
Description
feasibility trial
Time Frame
2 years
Title
To make a preliminary assessment of safety and efficacy of suprachoroidal viscobuckle.
Description
feasibility trial
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riti Desai
Phone
020 3299 1297
Ext
31297
Email
ritidesai@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Shohista Saidkasimova, FRCOphth
Phone
+44(0)1603288455
Email
shohista.saidkasimova@nnuh.nhs.uk
Facility Information:
Facility Name
Sunderland Eye Infimary
City
Sunderland
State/Province
Tyne And Wear
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Steel, FRCOphth
Email
David.Steel@chs.northy.nhs.uk
First Name & Middle Initial & Last Name & Degree
David Steel, FRCOphth
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louisa Wickham, FRCophtha
Facility Name
Guy's & St. Thomas' Hospital NHS Foundatrion Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alistair Laidlaw, MD, FRCOphth
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy L Jackson, PhD,FRCOpht
Phone
+44 20 3299 1297
Email
t.jackson1@nhs.net
First Name & Middle Initial & Last Name & Degree
Riti Desai, MSc,MPhil
Phone
+44 20 3299 1297
Email
ritidesai@nhs.net
First Name & Middle Initial & Last Name & Degree
Timothy L Jackson, PhD,FRCOpht
Facility Name
Norfolk and Norwich University Foundation Trust
City
Norwich
ZIP/Postal Code
NR47UY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shohista Saidkasimova, FRCOphth
Phone
44(0)1603288511
Email
shohista.saidkasimova@nnuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Shohista Saidkasimova, FRCOphth
Facility Name
Southend University Hospital NHS Foundation Trust
City
Southend
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aman Chandra, FRCOphth
Email
aman.chandra@southend.nhs.uk
First Name & Middle Initial & Last Name & Degree
Aman Chandra, FRCOphth

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28376555
Citation
Boden KT, Januschowski K, Szurman P. [Suprachoroidal Hydrogel Buckle - a New Minimal-Invasive Technique in Treatment of Rhegmatogenous Retinal Detachment]. Klin Monbl Augenheilkd. 2019 Mar;236(3):308-312. doi: 10.1055/s-0043-102947. Epub 2017 Apr 4. German.
Results Reference
background
PubMed Identifier
27482642
Citation
El Rayes EN, Mikhail M, El Cheweiky H, Elsawah K, Maia A. SUPRACHOROIDAL BUCKLING FOR THE MANAGEMENT OF RHEGMATOGENOUS RETINAL DETACHMENTS SECONDARY TO PERIPHERAL RETINAL BREAKS. Retina. 2017 Apr;37(4):622-629. doi: 10.1097/IAE.0000000000001214.
Results Reference
background
PubMed Identifier
27853956
Citation
Mikhail M, El-Rayes EN, Kojima K, Ajlan R, Rezende F. Catheter-guided suprachoroidal buckling of rhegmatogenous retinal detachments secondary to peripheral retinal breaks. Graefes Arch Clin Exp Ophthalmol. 2017 Jan;255(1):17-23. doi: 10.1007/s00417-016-3530-8. Epub 2016 Nov 16.
Results Reference
background
PubMed Identifier
22257789
Citation
Mitry D, Awan MA, Borooah S, Siddiqui MA, Brogan K, Fleck BW, Wright A, Campbell H, Singh J, Charteris DG, Yorston D. Surgical outcome and risk stratification for primary retinal detachment repair: results from the Scottish Retinal Detachment study. Br J Ophthalmol. 2012 May;96(5):730-4. doi: 10.1136/bjophthalmol-2011-300581. Epub 2012 Jan 18.
Results Reference
background
PubMed Identifier
23978624
Citation
Jackson TL, Donachie PH, Sallam A, Sparrow JM, Johnston RL. United Kingdom National Ophthalmology Database study of vitreoretinal surgery: report 3, retinal detachment. Ophthalmology. 2014 Mar;121(3):643-8. doi: 10.1016/j.ophtha.2013.07.015. Epub 2013 Aug 23.
Results Reference
background
PubMed Identifier
3808600
Citation
Poole TA, Sudarsky RD. Suprachoroidal implantation for the treatment of retinal detachment. Ophthalmology. 1986 Nov;93(11):1408-12. doi: 10.1016/s0161-6420(86)33553-x.
Results Reference
background
PubMed Identifier
27478632
Citation
Mohamed YH, Ono K, Kinoshita H, Uematsu M, Tsuiki E, Fujikawa A, Kitaoka T. Success Rates of Vitrectomy in Treatment of Rhegmatogenous Retinal Detachment. J Ophthalmol. 2016;2016:2193518. doi: 10.1155/2016/2193518. Epub 2016 Jul 13.
Results Reference
background

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Suprachoroidal Visco-buckling for the Treatment of Rhegmatogenous Retinal Detachment

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