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.: PACTR201712002861391 Date of Approval: 12/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Graft survival after penetrating keratoplasty in cases of trabeculectomy versus Ahmed valve implant
Official scientific title Graft survival after penetrating keratoplasty in cases of trabeculectomy versus Ahmed valve implant
Brief summary describing the background and objectives of the trial to assess the corneal graft survival rates after penetrating keratoplasty in cases of trabeculectomy versus Ahmed valve implant
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied corneal graft survival rate after PKP in glaucoma patients,Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2015
Actual trial start date 01/01/2015
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date 01/11/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Stopped early/ terminated
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group trabeculectomy surgery treatment of glaucoma 20
Control Group Ahmed valve treatment of glaucoma 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
history of penetrating keratoplasty complete data on records complicated surgery failed corneal grafts before glaucoma sigery 18 Year(s) 70 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 05/11/2017 local ethics committee of faculty of medicine .Alex univ
Ethics Committee Address
Street address City Postal code Country
khartum square alexandria 21259 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome graft clarty 2 years
Secondary Outcome intraocular pressure 2 years
Secondary Outcome visual acuity 2 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine. Alexa university khartum square alwxandria 21259 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
authors khartum squar alexandria 21259 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine.Alexandria university khartum square alexandria 21259 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
abdelhamid elhofi khartum square alexandria 21259 Egypt
hang helaly khartum square alexandria 21259 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator abdelhamid elhofi abdelhamidelhofi@yahoo.com 00201112241229 khartum square
City Postal code Country Position/Affiliation
alexandria 21259 Egypt faculty of medicine .Alex univ. ..assistant profesdor
Role Name Email Phone Street address
Public Enquiries hany helaly hany209209@yahoo.com 00201225466733 khartum square
City Postal code Country Position/Affiliation
alexandria 21259 Egypt assistant professor.Alex univ. faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries hany helaly hany209209@yahoo.com 00201225466733 khartum square
City Postal code Country Position/Affiliation
alexandria 21259 Egypt assistant professor .faculty of medicine .Alex univ
REPORTING
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