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.: PACTR201906888687731 Date of Approval: 10/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Trabeculectomy with conjunctival graft: A new technique for trabeculectomy.
Official scientific title Trabeculectomy with conjunctival graft: a new technique for surgical treatment of uncontrolled glaucoma.
Brief summary describing the background and objectives of the trial Glaucoma constitutes the first cause of irreversible blindness in the world. Trabeculectomy, a guarded sclerostomy introduced by Cairns in 1968 is the most widely used filtration surgery. In recent years, important changes have been introduced in order to make trabeculectomy safer and also more efficient. The reported success rates for primary trabeculectomies range from 67% to 84%.However, fibrosis of the sub-conjunctival tissue may lead to bleb failure, decreasing the long term success of trabeculectomy. With the introduction of adjunctive anti-metabolites, such as 5-fluorouracil (5-FU) and mitomycin-C (MMC), which significantly decrease the post-operative sub- conjunctival scarring, have improved the long term success of trabeculectomy. However, the use of adjunctive anti- metabolites during surgery have increased the incidence of bleb-related complications like thin avascular blebs, hypotony maculopathy, blebitis, and endophthalmitis. We propose a new modification to enhance the success rate of trabeculectomy by using conjunctival graft at the site of tenonectomy and scleral flap to act as a barrier against the aggressive regrowth of Tenon's Capsule into the trabeculectomy site thus preventing scarring and premature failure. The technique was inspired by the use of conjunctival graft to cover the bare area of sclera after excision of ptyregium. This research we report the results of using this technique in patients scheduled for trabeculectomy.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied glaucoma
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 09/04/2019
Actual trial start date 09/05/2019
Anticipated date of last follow up 10/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Trabeculectomy with conjunctival graft It is a surgical trial intervention done at time of surgery then follow up The use of conjunctival graft from the lower bulbar conjunctiva of the same patient, after periotomy then adquate tenonectomy suturing of the conjunctival graft in a semilunar fasion just beyond the site of scleral falp. Then the conventional steps of trabeculectomy is done, by creating a 3X3 mm rectangular scleral flap , dissection of the scleral flap towards clear cornea until the surgical limbus is reached. A one mm sclerostomy and peripheral iridotomy is performed, then suturing of the flap to its bed by 10/0 nylon sutures. suturing of the conjunctival in a tight fashion by continuois 8/0 vicryl sutures. 30
Control Group trabeculectomty past history The control group is the other eye who has had trabeculectomy done and failed due to scarring. not an active group 30 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with uncontrolled primary glaucoma in one eye with history of failed trabeculectomy in the other eye (done by the same surgeon) due to scarring. - Medically unfit patients - Patients with active inflammation - patients with neovascular glaucoma, vitrecomized patients - patients with corneal pathology hindering follow up of IOP - Patients with severe dry eye or chronic conjunctival pathology( e.g.: xerosis, severe trachoma, etc.) - 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Month(s) 80 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 08/04/2019 Medical Ethics Committee of Assiut Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine - Assiut University - Fifth Floor Assiut 71526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome -Absolute success of the trabeculectomy to decrease IOP lower than 20 mm Hg without medications. one week, one months, three months, 6 months and possible one year.
Primary Outcome Bleb functionality and grading one week, one months, three months, 6 months and possible one year.
Secondary Outcome adverse events and complications one week, one months, three months, 6 months and possible one year.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine and Assiut University Hospitals Assiut University Hospital Assiut 71526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Mahmoud Fathy Rateb Hassan Ophthalmology Department - Assiut University Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mahmoud Rateb Department of Ophthalmology- Assiut University Assiut 71526 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ziead H. El Daly Ophthalmology Department Assiut Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Rateb rateb@aun.edu.eg +201000612611 El Helaly Street - Borg El Sedfy - th floor
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Lecturer and Consultant of Ophthalmology
Role Name Email Phone Street address
Public Enquiries Mahmoud Rateb rateb@aun.edu.eg +201000612611 El Helaly Street - Borg El Sedfy - th floor
City Postal code Country Position/Affiliation
Assiut Egypt Lecturer and Consultant of Ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Rateb rateb@aun.edu.eg +201000612611 El Helaly Street - Borg El Sedfy - th floor
City Postal code Country Position/Affiliation
Assiut Egypt Lecturer and Consultant of Ophthalmology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes An excel sheet including all the individual data will be available upon completion of the study. Statistical Analysis Plan,Study Protocol IPD will be available May 2020 and up to two years All data will be accessible and free to use only after publication of this trial.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information