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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	PACTR
Last refreshed on:	29 May 2023
Main ID:	PACTR201312000712328
Date of registration:	23/11/2013
Prospective Registration:	No
Primary sponsor:	Office of Research, Innovation and Development (ORID), University of Ghana
Public title:	Trial of intra-operative adjuvant mytomycin C versus 5-Fluorouracil with trabeculotomy-trabeculectomy for developmental glaucoma
Scientific title:	Randomised Controlled Trial of intra-operative adjuvant mytomycin C versus 5-Fluorouracil with trabeculotomy-trabeculectomy for developmental glaucomas
Date of first enrolment:	11/06/2009
Target sample size:	60
Recruitment status:	Other
URL:	https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=712
Study type:	Interventional
Study design:	Parallel: different groups receive different interventions at same time during study,Randomised,simple randomisation using coin toss,Numbered containers
Phase:	Not Applicable

Countries of recruitment
Ghana

Contacts

Name:	Imelda-O. Dzifa Ofori Adjei
Address:	Korle-Bu 233 Accra Ghana
Telephone:	+ 233 206301838
Email:	dziffabella@gmail.com
Affiliation:	Ophthalmologist / Co-Investigator

Name:	Vera Adobea Essuman
Address:	Korle-Bu Accra Ghana
Telephone:	233244113337
Email:	vadessuman@yahoo.com
Affiliation:	Senior Lecturer

Key inclusion & exclusion criteria

Inclusion criteria: 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
Exclusion criteria: 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

Age minimum: 1 Day(s)
Age maximum: 15 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Developmental Glaucomas

Eye Diseases

Paediatrics

Eye Diseases
Surgery
Paediatrics
Developmental Glaucomas

Surgery

Intervention(s)

Combined trabeculectomy- trabeculotomy

Combined trabeculectomy-trabeculotomy + intraoperative Mytomicin C

Combined trabeculectomy- trabeculotomy + intraoperative 5 Fluorouracil

Primary Outcome(s)

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)

Secondary Outcome(s)

surgical complications

drug reactions / complications

Visual outcome

Secondary ID(s)

Source(s) of Monetary Support

University of Ghana Research Fund

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 23/06/2009
Contact:

University of Ghana Medical School's Ethics and Protocol Review Committee

Results

Results available:
Date Posted:
Date Completed:
URL:

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