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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901915134088 Date of Registration: 21/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Aqueous Suppressants for pediatric Ahmed Valve.
Official scientific title Early and prolonged administration of aqueous suppressants for prevention of hyperencapsulation with Ahmed Valve in refractory pediatric glaucoma.
Brief summary describing the background and objectives of the trial Ahmed valve in now widely used to control refractive glaucoma. Failure of the valve is usually related to persistent encapsulation. the early administration of aqueous suppressants appears to have an effect to reduce encapsulation. This effect has not been previously studied in pediatric population. In this study we report our results on using of early aqueous suppressants with pediatric Ahmed valve in two different protocols.
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: Drugs
Anticipated trial start date 02/10/2015
Actual trial start date 11/01/2016
Anticipated date of last follow up 08/04/2018
Actual Last follow-up date 08/04/2018
Anticipated target sample size (number of participants) 94
Actual target sample size (number of participants) 86
Recruitment status Completed
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 randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Aqueuos supressants Azarag , Brinzolamide - Timolol BID 3 months (twice daily in the first three months) . Then stop and add according to Intraocular Pressure (IOP) 41 Dose Comparison
Experimental Group Prologned Administration of Aqueous suppressants Azarga , Brinzolamide-Timolol Fixed Combination 12 months Early (start first week) and Prolonged (of 12 months)administration of aqueous suppressants. 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients younger than 16 years and diagnosed with refractory pediatric glaucoma including congenital glaucoma, juvenile glaucoma, aphakic/Pseudophakic glaucoma and glaucoma in vitrectomized eyes Exclusion criteria were previous AGV implantation, co-existing corneal pathology, inability to measure IOP accurately or primary tube failure. Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Day(s) 16 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 11/10/2015 the Committee of medical ethics of Assiut faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Assiut University- Assiut Faculty of Medicine Assiut 71536 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Presence or Absence of Hyperencapsulation phase which is defined as as thickened, vascularized bleb over AGV with IOP ≥ 21 mmHg in absence of tube malfunction. Primary tube failure was defined as tube malfunction or obstruction with aqueous drainage failure. Rescue needling of the bleb was postponed after 3 months post-operatively. one momth, 3 months, 6 months and 12 months
Secondary Outcome Adverse reactions 1 week, 1 month,3 months, 6 month and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut Univesity Hospital El Gamaa Street , Kornish El Ebrahimea Assiut 71536 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funding Ophthalmology Department Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Assiut University Hospital Assiut University- Faculty of Medicine Assiut 71526 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ziad H El DLY El Gomhoria Street Assiut 71111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mahmoud Rateb rateb@aun.edu.eg +201008348480 El Helaly Street
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Lecture of Ophthalmology Assiut University
Role Name Email Phone Street address
Principal Investigator Mahmoud Rateb rateb@aun.edu.eg +201008348480 El Helaly Street
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Lecture of Ophthalmology Assiut University
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Rateb rateb@aun.edu.eg +201008348480 El Helaly Street
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Lecture of Ophthalmology Assiut University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Eighty six eyes of eighty six children completed the 12-months follow up visits and fulfilled inclusion criteria. Baseline IOP was significantly reduced from 31.95 ± 9.1 mmHg to 18.17 ± 7.4 at 12 months (p-value < 0.05) in group A and from 32.7 ± 7.4 mmHg to 19.45 ± 6.9 at 12 months (p-value < 0.05) in group B. IOP differences among groups were statistically significant in 6, 9 and 12-month follow up visits with lower IOP in group A. in first 4 months, both groups exhibited similar rates of HEP (6 (13.3 %) eyes and 7 (17.1 %) eyes respectively at 4 months). HEP rate was significantly different between groups at 6 and 12 months (10 (22.2 %) eyes and 15 (36.6%) eyes respectively at 6-months, 14 (31.1 %) eyes and 19 (46.3%) eyes respectively at 12-months). 18/01/2019 18/01/2019
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks The protocol is not available online
Changes to trial information