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.: PACTR201906529708454 Date of Approval: 03/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical Outcomes Of Transepithelial Photorefractive Keratectomy Versus Femtosecond Laser Assisted Keratomulesis For Correction Of High Myopia In South Egyptian Population
Official scientific title Clinical Outcomes Of Transepithelial Photorefractive Keratectomy Versus Femtosecond Laser Assisted Keratomulesis For Correction Of High Myopia In South Egyptian Population
Brief summary describing the background and objectives of the trial Purpose: To evaluate the safety and efficacy of transepithelial photorefractive keratectomy (t-PRK) with adjuvant Mitomycin versus femtosecond laser assisted keratomileusis in correction of high myopia. Setting:Sohag Center for Lasik and Corneal Surgeries, Sohag, South Egypt Methods: Prospective randomized comparative study including divided randomly into two groups; Group A treated with t-PRK with adjuvant Mitomycin C (MMC) andGroup B treated withfemtosecond laser assisted keratomileusis.Visual acuity, spherical equivalent, corneal topography, pachymetry and keratometry were assessed for 12 months postoperatively.
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 15/03/2016
Actual trial start date 03/04/2016
Anticipated date of last follow up 27/04/2017
Actual Last follow-up date 31/05/2018
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Completed
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Transepithelial photorefractive keratectomy with Mitomycin C seconds A type of refractive surgery which is surface ablation with phototherapeutic keratectomy then the application of Mitomycin C 70 Active-Treatment of Control Group
Experimental Group Femtosecond Laser Assisted Keratomulesis seconds Refractive laser using femtosecond laser in LASIK surgery 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
high myopia (spherical equivalent refraction (SER) ≥ -6.00 D. 17) age 20–45 years LASIK is not possible for full correction due to thin cornea with residual stromal bed ≥ 280µm Emmetropia was the target with full correction of the refractive error. preoperative assessment of ocular topography, and included corneal dystrophy with topographic irregularity, pellucid marginal degeneration, formefruste keratoconus severe dry eye syndrome previous corneal or intraocular surgery history of current eyelid disease, or any form of keratitis patients with a history of keloid formation Patients with incomplete 12 months follow up were excluded as well Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 12/03/2016 Sohag Cornea and refractive surgery center
Ethics Committee Address
Street address City Postal code Country
ElGomhoria Street Sohag 82425 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome spherical equivalent 1st week, 1st month, 6 month, 12 month
Primary Outcome Uncorrected visual acuity 1st week, 1st month, 6 month, 12 month
Primary Outcome Best corrected visual acuity 1st week, 1st month, 6 month, 12 month
Secondary Outcome Complications 1st week, 1st month, 6 month, 12 month
Secondary Outcome Safety, efficacy and predictability indices at 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag Refractive center Sohag city Sohag 82425 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag cornea and refractive center El Gomhoria street Sohag Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dr Engy Mostafa Naser City Sohag 82425 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amr Mounir Naser City sohag 82425 Egypt
Osama Ali Mohamed Naser City Sohag 82425 Egypt
Hatem Ammar Naser City Sohag 82425 Egypt
Alahmady H Alsmman Naser City Sohag 82425 Egypt
Mahmoud Mohamed Farouk Naser City Sohag 82425 Egypt
Mohamed Gamal Elghobaier Naser City Sohag 82425 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Engy Mostafa engymostafa@yahoo.com +201005643587 Naser City
City Postal code Country Position/Affiliation
Sohag Egypt Sohag Faculty of Medicine
Role Name Email Phone Street address
Principal Investigator Amr Mounir dramrmonir@yahoo.com +201005026170 Naser City
City Postal code Country Position/Affiliation
Sohag Egypt Sohag Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Mahmoud Farouk drmfaroukophth@yahoo.co.uk +201000400883 Naser City
City Postal code Country Position/Affiliation
Sohag Egypt Sohag Faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Include the demographics of the participants along with preopertative and post operative data Study Protocol Within 12 months Principle investigator can be approached to access data Data released would be the excel sheet
URL Results Available Results Summary Result Posting Date First Journal Publication Date
none Yes The preoperative mean spherical equivalent refraction (SER) was -8.86±1.81and -9.25± 1.70 D; in t-PRK MMC group and Femto-Lasik respectively (P = 0.99)which improved to -0.65± 0.43D and -0.69±0.50 D at 12 months follow up. Mean SER remained stable during the 12 months of follow-up, with no statistically significant difference between the two groups (P =0.64). In t-PRK MMC group;only six eyes needed retreatment after six months of follow up. And two eyes showed haze (one reversible haze grade 2, while the other had dense irreversible haze grade 4). 02/12/2019 26/06/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks none
Changes to trial information