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.: PACTR201208000401104 Date of Approval: 26/07/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE Ex-PRESS MINI SHUNT VERSUS TRABECULECTOMY IN AFRICAN PATIENTS: A RANDOMIZED CONTROLLED TRIAL
Official scientific title THE Ex-PRESS MINI SHUNT VERSUS TRABECULECTOMY IN AFRICAN PATIENTS: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial The Ex-PRESS Mini Shunt (EMS) is a miniature non-valved stainless steel device which when implanted under the scleral flap, diverts aqueous humour from the anterior chamber to the subscleral space. Insertion of this has been shown to reduce intraoperative time, reduce the risk of bleeding and lessen post-operative inflammation. There are few published data comparing EMS versus trabeculectomy. The objective is to compare the efficacy and safety of EMS to trabeculectomy in African patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EMS Vs TRAB
Disease(s) or condition(s) being studied Glaucoma surgical intervention
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 17/10/2011
Actual trial start date 24/10/2011
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple radomisation whereby patient picks a number either 1 for EMS or 2 for TRAB The papers with the numbers were folded and put into a box, from which the patient picked from with their eyes closed. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Express Mini shunt (EMS) insertion N/A N/A The Ex-PRESS Mini Shunt is a miniature non-valved stainless steel device which when implanted under the scleral flap, diverts aqueous humour from the anterior chamber to the subscleral space. 30
Control Group Trabeculectomy with mitomycin C N/A N/A Conventional trabeculectomy with mitomycin C is a standard filtration surgery used wildwide to control intraocular pressure. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18 to 90 years, inclusive. Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure > 18 mm Hg and < 40mm Hg. Glaucoma drainage surgery as planned surgical procedure. Primary Open Angle Glaucoma or pseudoexfoliative glaucoma. Black African ethnicity. Unwilling or unable to give consent or unwilling to accept randomization. Inability to attend follow-up visits Visual acuity of ¿no light perception¿ (NLP). Previous filtering or cyclodestructive procedure in the same eye. Previous ocular procedure involving the conjunctiva e.g. vitrectomy, scleral buckling, cyclodestructive procedure. Previous cataract extraction (phacoemulsification, small incision cataract surgery, extra capsular cataract extraction). Conjunctival scarring precluding trabeculectomy superiorly. Aphakia. Any secondary cause of glaucoma. Angle closure glaucoma. Need for glaucoma surgery combined with other ocular procedures e.g cataract extraction, penetrating keratoplasty, retinal surgery. Active proliferative diabetic retinopathy and/or active iris neovascularisation. Pregnant or nursing women Unwilling to discontinue contact lens use after surgery. Chronic or recurrent uveitis. Severe posterior blepharitis. 18 Year(s) 90 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 28/01/2011 KNH/UON Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Rd, off Ngong Rd Nairobi KNH Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean intraocular pressure compared between treatment groups Day 1 post operative Week 1 post operative Month 1 post operative Month 3 post operative Month 6 post operative Year 1 post operative
Secondary Outcome Comparison of surgical complications between the 2 groups Day 1 post operative Week 1 post operative Month 1 post operative Month 3 post operative Month 6 post operative Year 1 post operative
Secondary Outcome Comparison of patients achieving complete success, qualified success, or failure in each group. Day 1 post operative Week 1 post operative Month 1 post operative Month 3 post operative Month 6 post operative Year 1 post operative
Secondary Outcome Number of additional surgical procedures in each group Day 1 post operative Week 1 post operative Month 1 post operative Month 3 post operative Month 6 post operative Year 1 post operative
Secondary Outcome Change in visual acuity over time Day 1 post operative Week 1 post operative Month 1 post operative Month 3 post operative Month 6 post operative Year 1 post operative
Secondary Outcome Change in glaucoma medication over time Day 1 post operative Week 1 post operative Month 1 post operative Month 3 post operative Month 6 post operative Year 1 post operative
Secondary Outcome Difference in bleb appearanc eover time between the 2 groups Day 1 post operative Week 1 post operative Month 1 post operative Month 3 post operative Month 6 post operative Year 1 post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital/ University of Nairobi, Department of Ophthalmology Ngong Road Nairobi 30197 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
ALCON LABORATORIES INC. 6201 South Freeway Fortworth Texas 76134 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ALCON LABORATORIES INC. 6201 South Freeway Fortworth Texas 76134 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof. Karim Damji 10240 Edmonton Kinsway Avenue Canada
Dr. Christopher Rudnisky 10240 Edmonton Kinsway Avenue Canada
Dr. Yvonne Buys Toronto Western Hospital, 6th Fl. Rm 6EW405 Toronto, Ontario 399 Bathurst Str. Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sheila Marco sheilamarco@yahoo.co.uk +254 722 270 499
City Postal code Country Position/Affiliation
Nairobi 19785 00100 Kenya Lecturer
Role Name Email Phone Street address
Public Enquiries Rodgers Mieno rodgers_enrique@yahoo.com +254 724 291 669
City Postal code Country Position/Affiliation
Nairobi 19785 00100 Kenya Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Sheila Marco sheilamarco@yahoo.co.uk +254 722 270 499
City Postal code Country Position/Affiliation
Nairobi 19785 00100 Kenya Lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information