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.: PACTR201906462665442 Date of Approval: 24/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lasik and Anisometropia
Official scientific title The role of lasik in Anisometropia
Brief summary describing the background and objectives of the trial Anisometropia is marked inequality in the refraction of the two eyes a difference of more than two diopters. In certain types of anisometropia, the visual cortex of the brain will not use both eyes together (binocular vision) , and will instead suppress the central vision of one of them.
Type of trial RCT
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 Diagnosis / Prognosis
Anticipated trial start date 15/07/2019
Actual trial start date 15/07/2019
Anticipated date of last follow up 15/08/2019
Actual Last follow-up date 01/11/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Recruiting
Publication URL https://ufile.io/rp9qc
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 Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group uncontrolled 6 month uncontrolled no lasik no glasses 10 Placebo
Experimental Group lasik group 3 month lasik procedure 20
Experimental Group glasses group 3 month glasses prescription 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- This study will patients age more than 6 years old with clear cornea 2- able and willing to give written informed consent and comply with the requirement of the study protocol 3- error of refraction difference in the two eyes not less than 2 diopater 1- Hazy cornea which can mask the result 2- Localized opacities can give false epithelial thickness 3- Erosions and which can affect mapping and give false results 4- Patients with topographic evidence of keratoconus. 5- Patients who are pregnant or nursing. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 6 Year(s) 30 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
No 15/07/2019 sohag university
Ethics Committee Address
Street address City Postal code Country
sohag university st sohag 82524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual cuity 3 months
Secondary Outcome difference between lasik and glasses group 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag eye centre sohag university st sohag Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Marcos Zarif Sobhy shanhorya st qena Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohmad Iqbal Hafez sohag university st sohag Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marcos Zarif dr.marcoszarif@gmail.com 01226322362 shanhorya st
City Postal code Country Position/Affiliation
qena Egypt Residant
Role Name Email Phone Street address
Public Enquiries Mohmad Iqbal dr_m_iqbal@yahoo.com 01068559840 sohag university st
City Postal code Country Position/Affiliation
sohag Egypt Assistant Prof
Role Name Email Phone Street address
Scientific Enquiries Ahmad Gad ahmad1461976@yahoo.com 01003350615 sohag university st
City Postal code Country Position/Affiliation
sohag Egypt Dr
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Visual acuity over : 1st visit 1st month 3rd month Statistical Analysis Plan 6 months anisometropia lasik
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://ufile.io/rp9qc 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