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.: PACTR202404885116779 Date of Registration: 17/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title treatment of idiopathic macular hole
Official scientific title A Comparative Study Between Classically Inverted And Temporally Inverted Internal Limiting Membrane Flap Technique In Treatment Of Stage IV Idiopathic Macular Hole
Brief summary describing the background and objectives of the trial A full-thickness retinal tissue defect affecting the anatomic fovea and, particularly, the foveola of the eye is referred to as a macular hole. the gold standard management of the macular hole is the classical inverted internal limiting membrane flap but some authors suggest a new technique using a temporal inverted internal limiting membrane flap which may have superior anatomical and functional results than the classical method. The study's objective was to compare the visual and anatomical results of using a temporal inverted internal limiting membrane flap and a classical inverted internal limiting membrane flap in the surgical closure of stage IV idiopathic macular holes
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2024
Actual trial start date 01/03/2024
Anticipated date of last follow up 13/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group inverted internal limiting membrane flap 30 minutes classical inverted internal limiting membrane flap in surgical closure of stage IV idiopathic macular holes 20 Active-Treatment of Control Group
Experimental Group temporal inverted internal limiting membrane flap 30 minutes temporal inverted internal limiting membrane flap in surgical closure of stage IV idiopathic macular holes 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: above 10 years old. Idiopathic stage IV full-thickness macular hole by clinical and tomographic diagnosis (> 400 μm). Sex: both males and females are included in the study • Patients less than 10 years old. • Patients with partial thickness macula hole. • Patients with optical media opacities like total corneal opacity. • Patients with other causes of diminution of vision like advanced glaucoma or optic atrophy, amblyopia. • Patients with diabetic retinopathy, pan-retinal photocoagulation, inflammatory eye diseases, and high myopia (≥ − 6 D) • Patients with past history of vitrectomy and macular hole repair surgery. 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 85 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 10/11/2020 the research ethics committee of faculty of medicine Al azhar university
Ethics Committee Address
Street address City Postal code Country
Al-Azhar university, Assiut branch, 71524 king Faisal St Assuit 2067010 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the anatomical results in surgical closure of stage IV idiopathic macular holes. post operative in the next day after intervention
Secondary Outcome the visual results in surgical closure of stage IV idiopathic macular holes. 6 months post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar university king fisal st Assuit Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source king faisal Assuit Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Azhar Assuit university king faisal Assuit Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Fathi ibrahimfathi.if65@gmail.com 00201068027316 Deshna st
City Postal code Country Position/Affiliation
qena Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Hassan Hegazy Hhegaz@hotmail.com 00201006616687 new cairo st
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Public Enquiries Ashraf mohammed silicon2023@gmail.com 00201060293796 nag hammady st
City Postal code Country Position/Affiliation
qena Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication. open
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