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.: PACTR201508001201385 Date of Approval: 14/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between Trabeculectomy surgery outcomes with two different methods of application of Mitomycin C
Official scientific title A comparison of Trabeculectomy surgery outcomes in adutls with Mitomycin C applied by intra Tenon's injection versus Sponge method
Brief summary describing the background and objectives of the trial Trabaeculectomy is considered the most common glaucoma filtration surgery, introduced by Cairns in 1965.1 It is based upon producing a controlled, scar-limited fistula stable enough to maintain adequate aqueous outflow from the anterior chamber and subconjunctval space (sub bleb space). The healing process of the body tends to enhance scarring of the conjunctiva and sclera. Several surgical and pharmacologic techniques have been introduced to enhance the success in eyes with poor surgical prognoses. Mitomycin C (MMC) has been introduced as an alkylating agent to inhibit conjunctival scarring Several randomized controlled trials of intraoperative MMC compared to placebo or no adjunct in trabeculectomy surgery revealed a reduction of the relative risk of surgical failure. Complications reported in the trials included wound leaks, choroidal effusions, suprachoroidal hemorrhage, hypotony, hyphema, and cataract.4 Cystic, avascular blebs usually developed with intraoperative MMC administration. Such blebs may lead to overhanging on the cornea and necessitate bleb revision to prevent late bleb leakage and subsequent bleb infection. The most popular method for MMC application with trabeculectomy is by using a sponge for very short time applied over the scleral bed and Tenon¿s capsule. Mitomycin can be used with the same manner during needling post opertatively which is reported to increases the success of the trab surgery and decrease encapsulation and scarring. Therefore, MMC can be injected at the time of surgery using hypodermic 30G needle before doing conjunctival dissection. To our knowledge this study is the first prospective study to compare the success rate and complications of trabeculectomy with adjunctive MMC applied with either methods in both adults and children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Glaucoma,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/05/2015
Actual trial start date 02/04/2015
Anticipated date of last follow up 15/09/2016
Actual Last follow-up date 21/09/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
U1111-1172-1727 Universal Trial Number
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 Ramdomization by tossing sealed opaque envelops Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Sponge MMC 0.2% 3 min Sponge soaked with MMC over scleral flap 50 Active-Treatment of Control Group
Experimental Group Intra Tenon's MMC 0.3 ml , 0.2% 10 min Intra Tenon Injection of MMC 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Adult Patients undergoing trabeculectomy surgery with the clinical diagnosis of glaucoma in and over 18 years of age. 2- Children with congenital glaucoma, undergoing trabeculectomy surgery. 1- Prior glaucoma surgery except trabecular or iris based laser procedure 2- Prior Cyclodestructive procedures 3-Abnormal cornea that would make IOP measurements unreliable 4- Contraindication to the use of Mitomycin C (Pregnancy, Corneal or scleral chronic disease , connective tissue disease) 5- Inability to attend follow up visits 6- Intraocular pressure greater than 21 at postoperative week 1 (represents primary failure of the trabeculectomy) 7 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 16/03/2015 Assiut Medical Committee
Ethics Committee Address
Street address City Postal code Country
Assiut University-Faculty of Medicine Assiut 71526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraocular pressure (IOP) 3 months, 6months and 12 months
Secondary Outcome 1- Bleb grading and presence of cystic blebs or encapsulation 3 month, 6 monhts and 12 months
Secondary Outcome 2- adverse reactions same
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut University Ophthalmology Dept-Faculty of Medici Assiut 71526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Assiut University Assiut 71526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Assiut University Assiut 71526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Fathy Rateb Hassan Ophthalmology Department - Faculty of Medicine Assiut 71526 Egypt
Mohammed Shehata Hussien Ophthalmology Dept-Faculty of Medici Assiut 71526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Rateb rateb@aun.edu.eg +201008348480 Ophthalmology Department - Assiut University
City Postal code Country Position/Affiliation
Assiut 71526 Egypt Lecturer of Ophthalmology
Role Name Email Phone Street address
Public Enquiries Mahmoud Rateb rateb.cvec@gmail.com +201008348480 Ophthalmology Dept-Faculty of Medici
City Postal code Country Position/Affiliation
Assiut University 71526 Egypt Lecturer of Ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Rateb rateb@aun.edu.eg +201008348480 Ophthalmology Department - Assiut University
City Postal code Country Position/Affiliation
Assiut 71526 Egypt Lecturer of Ophthalmology
REPORTING
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Result URL Hyperlinks
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