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.: PACTR201712002858314 Date of Approval: 12/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between internal limiting membrane inverted flap and graft techniques for idiopathic large macular holes
Official scientific title Comparison between internal limiting membrane inverted flap and graft techniques for idiopathic large macular holes
Brief summary describing the background and objectives of the trial Idiopathic macular hole surgery, especially large ones > 400 microns, may show failure of the technique. Several modifications have been made to achieve higher rate of anatomical success. 1 Suggested techniques include the use of internal limiting membrane (ILM) inverted flap or graft for recurrent cases. This may help to achieve anatomical closure of the large macular hole. 2 Aim To compare between ILM inverted flap technique and ILM graft technique for idiopathic large macular holes.. METHODS: This is a retrospective comparative interventional clinical study. The study will include 40 eyes divided into two groups. The first group will include eyes with large idiopathic macular hole undergoing surgery with inverted ILM flap technique. The second group with undergo surgery using ILM graft technique. Patients will be followed up after the surgery. Best corrected visual acuity, anatomical closure rates, and any complications will be recorded. Results: The results will be analyzed statistically and any significance will be noted and tabulated
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Macular hole
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 20/12/2017
Actual trial start date 20/12/2017
Anticipated date of last follow up 20/06/2018
Actual Last follow-up date 20/06/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
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 Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group inverted ILM flap technique The first group will include eyes with large idiopathic macular hole undergoing surgery with inverted ILM flap technique. 20
Control Group ILM graft technique The second group with undergo surgery using ILM graft technique. 29
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
eyes with large idiopathic macular hole > 18 years complications during surgery lost of follow up 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 01/11/2017 Ethics committee of Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
khartoum square alexandria 21259 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome anatomical closure of the macular hole 6 months
Secondary Outcome best corrected viusal acuity 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine, Alexandria University Khartoum Square Alexandria 21259 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors Khartoum Square Alexandria 21259 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors Khartoum Square Alexandria 21259 Egypt Hospital
Primary Sponsor Authors Khartoum Square Alexandria 21259 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohsen Aboushousha Khartoum Square Alexandria 21259 Egypt
Hany Helaly Khartoum Square Alexandria 21259 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohsen Aboushousha drmohsenmd@hotmail.com 00201112241229 Khartoum Square
City Postal code Country Position/Affiliation
Alexandria 21259 Egypt Faculty of Medicine, Alexandria University
Role Name Email Phone Street address
Public Enquiries Hany Helaly hany209209@yahoo.com 00201112241229 Khartoum Square
City Postal code Country Position/Affiliation
Alexandria 21259 Egypt Assistant Professor, Faculty of Medicine, Alexandria Universtiy
Role Name Email Phone Street address
Public Enquiries hany helaly hany209209@yahoo.com 00201112241229 khartoum square
City Postal code Country Position/Affiliation
alexandria 21259 Egypt assistant professor, faculty of medicine, alex university, egypt
Role Name Email Phone Street address
Scientific Enquiries hany helaly hany209209@yahoo.com 00201112241229 khartoum square
City Postal code Country Position/Affiliation
alexandria 21259 Egypt assistant professor, faculty of medicine, alex university, egypt
Role Name Email Phone Street address
Scientific Enquiries Hany Helaly hany209209@yahoo.com 00201112241229 Khartoum Square
City Postal code Country Position/Affiliation
Alexanfria 21259 Egypt Assistant Professor, Faculty of Medicine, Alexandria University
REPORTING
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