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.: PACTR201312000712328 Date of Approval: 23/11/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Trial of intra-operative adjuvant mytomycin C versus 5-Fluorouracil with trabeculotomy-trabeculectomy for developmental glaucoma
Official scientific title Randomised Controlled Trial of intra-operative adjuvant mytomycin C versus 5-Fluorouracil with trabeculotomy-trabeculectomy for developmental glaucomas
Brief summary describing the background and objectives of the trial Paediatric glaucomas are a heterogenous group of diseases and syndromes in children caused by elevated intraocular pressure (IOP) leading to optic nerve and other ocular damage. These usually result from structural maldevelopment of anterior segments and angle structures. Developmental glaucomas are associated with developmental anomaly of the filtration angle alone or in association with other ocular or systemic developmental anomalies that are present at birth. Surgical interventions are the main treatment for the developmental glaucomas. Goniotomy and trabeculotomy have traditionally been procedures of choice, and also trabeculectomy, a common procedure for adults widely used especially by General Ophthalmologist for its treatment. Recent reports in the literature have found combined trabeculotomy-trabeculectomy, CTT, to yield superior results in comparison with conventional procedures. These surgical procedures are however associated with varying success rates and challenges, especially in severe cases, as found also in Ghanaian children with developmental glaucomas. There is the need to find an enhanced surgical procedure that will offer better long term success with less ocular complications for the developmental glaucomas in Ghana. b) General Aim Randomised controlled trial to compare the outcome of combined trabeculotomy-trabeculectomy with and without intra-operative adjuvant mytomycin C versus 5-Fluorouracil for developmental glaucomas in Ghanaian children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Developmental Glaucomas,Eye Diseases,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 11/06/2009
Actual trial start date 17/09/2009
Anticipated date of last follow up 10/10/2013
Actual Last follow-up date 10/10/2013
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 48
Recruitment status Closed to recruitment,follow-up continuing
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
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using coin toss Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Combined trabeculectomy- trabeculotomy surgery only 16 Active-Treatment of Control Group
Experimental Group Combined trabeculectomy-trabeculotomy + intraoperative Mytomicin C 0.2mg/ml & 0.4mg/ml 3 minutes 16
Experimental Group Combined trabeculectomy- trabeculotomy + intraoperative 5 Fluorouracil 25mg/ml & 50mg/ml 5 minutes 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All cases of developmental glaucoma with or without a previous history of glaucoma surgery, aged less than 16 years, with written informed consents from their parents/ guardians All children with traumatic glaucoma, drug related (steroid- induced) glaucoma, aphakic glaucoma, inflammatory glaucoma, glaucoma associated with ocular tumours and other causes of non-developmental glaucomas 1 Day(s) 15 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 23/06/2009 University of Ghana Medical School's Ethics and Protocol Review Committee
Ethics Committee Address
Street address City Postal code Country
Korle- Bu Accra 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surgical success is defined as: Intraocular Pressure (IOP) ¿21mmHg without anaesthesia and IOP¿16mmHg under general anaesthesia, stable corneal diameter and clear cornea, stable optic disc cupping and stable visual fields (in older children) 1 Month 3 Months 6 months 12 months 18 months 24 months 30 months 36 months,
Secondary Outcome Visual outcome 1 Month 3 Months 6 months 12 months 18 months 24 months 30 months 36 months,
Secondary Outcome surgical complications 1 Month 3 Months 6 months 12 months 18 months 24 months 30 months 36 months,
Secondary Outcome drug reactions / complications 1 Month 3 Months 6 months 12 months 18 months 24 months 30 months 36 months,
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ophthalmology unit, Korle-Bu teaching hospital, Korle- Bu Accra 233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Ghana Research Fund Legon Accra 233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Office of Research, Innovation and Development (ORID), University of Ghana Legon Accra 233 Ghana University
COLLABORATORS
Name Street address City Postal code Country
Vera Adobea Essuman Korle-Bu Accra 233 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vera Adobea Essuman vadessuman@yahoo.com 233244113337 Korle-Bu
City Postal code Country Position/Affiliation
Accra Ghana Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Imelda-O. Dzifa Ofori Adjei dziffabella@gmail.com + 233 206301838 Korle-Bu
City Postal code Country Position/Affiliation
Accra 233 Ghana Ophthalmologist / Co-Investigator
Role Name Email Phone Street address
Scientific Enquiries Vera Adobea Essuman vadessuman@yahoo.com 233244113337 Korle-Bu
City Postal code Country Position/Affiliation
Accra Ghana Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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