Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201906908757116 Date of Approval: 06/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Xen 45 implant versus Deep Sclerectomy in the surgical treatment of open angle glaucoma: A comparative study in a South African tertiary hospital
Official scientific title Xen 45 implant versus Deep Sclerectomy in the surgical treatment of open angle glaucoma: A comparative study in a South African tertiary hospital
Brief summary describing the background and objectives of the trial Problem statement Deep sclerectomy augmented with MMC has a proven track record for use in open-angle glaucoma patients that require surgery to control their intraocular pressure, but the procedure is not without complications and is not always successful. Newer glaucoma surgical devices, of which the Xen 45 implant is an example, offer the following potential advantages over conventional surgery: • Shorter surgical time • Fewer complications These benefits may improve the cost-effectiveness of the Xen 45 implant, an otherwise expensive device, but only if the device is equally effective in lowering IOP and if the requirements for post-operative follow-up visits, procedures and medications are comparable. It is not known, therefore, whether this procedure is a feasible alternative to deep sclerectomy in the resource-constrained setting of the Charlotte Maxeke Johannesburg Academic (CMJA) Hospital in Johannesburg, South Africa. Research Question Is the Xen 45 gel implant a cost-effective alternative procedure to deep sclerectomy at CMJA Hospital? Aim of the study To compare the cost-effectiveness of Xen implants versus deep sclerectomy in patients with open-angle glaucoma over a six-month period. Study objectives Primary objective • To cost Xen implant surgery and follow-up over a six-month period and compare it to the cost of deep sclerectomy surgery and six-month follow-up at CMJAH Secondary objectives • To compare IOP outcomes in the first two years after Xen implant surgery with those following deep sclerectomy surgery • To compare the success and failure rates of the two procedures at six months, one and two years post-operatively • To compare the post-operative requirement for glaucoma medication following Xen implants with that following deep sclerectomy surgery • To compare the complication (intra- and post-operative) rates of Xen implant surgery with deep sclerectomy surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 30/05/2019
Actual trial start date
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 12
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Xen 45 implant N/A This will be performed with local anaesthesia. The conjunctival flap will be fornix based. One paracentesis will provide access to the anterior chamber that will be formed with a cohesive viscoelastic. MMC (0.4mg/ml) will be applied to the scleral bed for 2 minutes and then washed out. The device will be inserted ab-externo 3mm posterior to the limbus and advanced through the sclera to enter the eye anterior to the trabecular meshwork. The position of the stent will be confirmed ab-interno with a gonioscopy lens and in the subconjuctival space with direct visualisation and employing gentle movement of the device. The conjunctiva will be closed with 8-0 vicryl sutures. The viscoelastic will be washed out and the wounds hydrated. Intracameral avastin will be injected and topical antibiotics applied. A subconjunctival steriod injection will be administered to the inferior conjunctiva. 12
Control Group Deep sclerectomy with mitomycin C N/A N/A This will be performed with local anaesthesia. The conjunctival flap will be fornix based. A 5mm x 5mm x 5mm limbal-based half-thickness scleral flap will be dissected into clear cornea. MMC (0.4mg/ml) will be applied to the scleral bed for 2 minutes and then washed out. A second, deep scleral flap will be dissected to deroof the Schlemm canal. A paracentesis will provide access to the anterior chamber. The juxtacanalicaular membrane will be excised and thereafter a descemet’s window will be fashioned before excision of the deep scleral flap. The superficial flap will be sutured with 4 separate 10-0 nylon sutures. The conjunctiva will be closed with 8-0 vicryl sutures. Intracameral avastin will be injected and topical antibiotics applied. A subconjunctival steriod injection will be administered to the inferior conjunctiva. 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• CMJAH eye clinic adult patients (18 years of age or older) • Bilateral open angle glaucoma (primary open-angle glaucoma (POAG), exfoliation glaucoma (XFG) or pigment dispersion syndrome (PDS)) requiring surgery to both eyes: o GLAUCOMA DIAGNOSIS will be based on the appearance of the optic nerve head, open angles on gonioscopy, optical coherence tomography (OCT) structural assessments and humphrey visual field changes o REQUIREMENTS FOR SURGERY:  IOP greater than 18mmHg despite maximal tolerated medical therapy  Progression of optic nerve cupping, thinning of the retinal nerve fibre layer or progression of visual field defects despite maximal tolerated medical therapy • Post-traumatic and angle-recession glaucoma • Neovascular glaucoma • Uveitic glaucoma • Occludable angles on gonioscopy • Previous intra-ocular surgery other than uncomplicated cataract surgery • Prior conjunctival surgery or pathology • Active inflammation (blepharitis, conjunctivitis, keratitis, uveitis) • Impaired episcleral venous pressure (for example Sturge-Weber syndrome, nanophthalmos or thyroid eye diseases 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/12/2018 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Phillip Tobias Building, 29 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Cost • Surgical time • Disposables and devices • Post-operative medication • Follow-up visits • Additional procedures 6 months
Secondary Outcome Intraocular pressure Pre-operatively and at day 1, week 1, months 1, 2 and 3 and 6 months post-operatively and thereafter every 3 months until two years post-operatively
Secondary Outcome Success • A COMPLETE SUCCESS will be defined as an IOP of less than or equal to 18mmHg and an IOP reduction greater than or equal to 30% without glaucoma medication or compared with a pre-operative level. In addition there must be no progression of optic nerve cupping or visual field changes • A QUALIFIED SUCCESS will be defined as an IOP less than or equal to 18mmHg with glaucoma medication or an IOP reduction of less than 30% compared with a pre-operative level in the absence of glaucoma progression • A QUALIFIED FAILURE will be defined as an IOP greater than 18mmHg despite glaucoma medication but without detectable optic nerve or visual field deterioration • A COMPLETE FAILURE will be an eye requiring a second glaucoma drainage surgery or losing visual function 2 years post-operatively
Secondary Outcome Number of glaucoma medications used Pre-operatively and at day 1, week 1, months 1, 2 and 3 and 6 months post-operatively and thereafter every 3 months until two years post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Charlotte Maxeke Johannesburg Academic Hospital Jubilee Road, Parktown Johannesburg 2195 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Carnegie Corporation of New York 437 Madison Avenue, New York New York 10022 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand Faculty of Health Sciences Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Mathabo Mofokeng Charlotte Maxeke Johannesburg Academic Hospital, Jubilee road, Parktown Johannesburg 2193 South Africa
Prescilla January Charlotte Maxeke Johannesburg Academic Hospital, Jubilee road, Parktown Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Susan Williams susan.williams@wits.ac.za +27824676999 87 Craigtowne, 1 Richmond avenue, Craighall Park
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Lecturer
Role Name Email Phone Street address
Scientific Enquiries Susan Williams susan.williams@wits.ac.za +27824676999 87 Craigtowne, 1 Richmond avenue, Craighall Park
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Lecturer
Role Name Email Phone Street address
Public Enquiries Susan Williams susan.williams@wits.ac.za +27824676999 87 Craigtowne, 1 Richmond avenue, Craighall Park
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified dataset Informed Consent Form,Study Protocol Baseline data - within 1 year of start date, cost data within 18 months of start date, final data from September 2023 Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information