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: www.pactr.org
Trial no.: PACTR201901543722087 Date registered: 07/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lasik-induced corneal changes after correction of hyperopia with and without application of Mitomycin C
Official scientific title Lasik-induced corneal changes after correction of hyperopia with and without application of Mitomycin C
Brief summary describing the background and objectives of the trial Purpose: To assess the role of intraoperative mitomycin-C (MMC) application during hyperopic LASIK correction (+1.00 D to +6.00 D) by examining topographic corneal changes and incidence of regression over a one-year follow-up period. Methods: This comparative randomized control study included 136 eyes of 68 hyperopic patients divided into two groups; Group A included 68 eyes of 34 patients that had LASIK with the application of 0.02% MMC for 10 seconds on the stromal bed after excimer laser treatment, and group B included 68 eyes of 34 patients that had LASIK without MMC application. Uncorrected distance visual acuity (UDVA), refraction, keratometry and topography were recorded at 1st week and 1st, 3rd, 6th, and 12th months postoperation. Predictability and treatment efficacy were also recorded at the end of the follow-up period.
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 Treatment: Surgery
Anticipated trial start date 01/06/2016
Actual trial start date 01/06/2016
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date 31/10/2018
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 68
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 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lasik For hyperpic patients with use of Mitomycin C No use of Mitomycin C at all in this group Lasik for Hyperopic patients was done only without Mitomycin C the group includes 68 eyes of 34 subjects 68 Active-Treatment of Control Group
Experimental Group Lasik With The Use of Mitomycin C Mitomycin C under the Lasik Flap concentration of 0.02 % for 10 seconds Lasik for hyperopic Patints using Mitomycin C under the Lasik Flap concentration of 0.02 % for 10 seconds 68
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hyperpic patients +1 to +6 D Stable refraction Previous ocular disease Systemic diseases that affect stability of refraction systemic disease that may affect corneal healing Topographic changes that prevent Lasik Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 50 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 06/04/2016 Research Ethics Committee faculty of medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Ring Road Ismailia 41111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of Regression 1 week, 1st ,3rd,6th 12th month
Secondary Outcome Topographic corneal changes 1 week, 1st ,3rd,6th 12th month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez Canal university hospital Ophthalmology Department ring Road, Ismailia, Egypt Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed A Abdelghany Ring Road Ismailia 41111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of ophthalmology Faculty of Medicine Suez Canal University Ring Road Ismailia 41111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ehab mohamed Mowad Ring road Ismailia Egypt
Osama Elbassiouny Ring road Ismailia Egypt
Mohsen Saad Badawy Ring road Ismailia Egypt
Amr Abdelfattah Gaballah Ring road Ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Anwar Abdelghany ahmedanwar50@hotmail.com +201005211481 Ring Road
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Associate professor of ophthalmology
Role Name Email Phone Street address
Public Enquiries Ahmed Anwar Abdelghany ahmedanwar50@hotmail.com +201005211481 Ring Road
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Associate professor of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Ehab Mowad drehab_eye@hotmail.com +201227513043 Ring Road
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer of Ophthalmology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Better predictability was noted in group A than in group B at the 6 month and 12 month follow-up visits, with a mean cycloplegic refraction SE of +0.5 ± 0.31 D in group A and +0.67 ± 0.39 D in group B at the 6 month visit, and +0.63 ± 0.37 D in group A and +0.89 ± 0.48 D in group B at the 12 month visit. The efficacy of the treatment at the end of the follow up period was better in group A than in group B. Group A showed fewer topographic corneal changes than group B. 17/01/2019 17/01/2019
Result URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
still not published This study involved 47% male and 53% female patients. Specifically, 68 eyes of 34 patients were involved in group A, where 44.1% were male patients and 55.9% were female patients, and 68 eyes of 34 patients were involved in group B, where 52.9% were male patients and 47.1% were female patients. The mean age of the study populations was 35.7 ± 11.3 years of age for group A and 34 ± 10.7 years of age for group B. The preoperative CDVA was 0.96 ± 0.08 in group A and 0.95 ± 0.07 in group B. The refraction was +3.2 ± 1.1 D in group A and + 3.3 ± 1 D in group B. Keratometry was 42 ± 1.5 D in group A and 41.6 ± 1.5 D in group B. The mean corneal thickness (at the 6-mm optical zone) was 553.8 ± 11.8 µm in group A and 551.3 ± 11.5 µm in group B. No recorded adverse events Refraction and Keratometry Changes Are The Main Outcomes
Link To Protocol
still not published
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 14/01/2019 correction still not publshed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 14/01/2019 correction to include maximum age of 50 years Adult: 19 Year-44 Year Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/01/2019 I did not understand the comment on this section ,because of the recruitment center is clear suez Canal university hospital, ring Road, Ismailia, Egypt, Ismailia, 41111, Egypt suez Canal university hospital Ophthalmology Department, ring Road, Ismailia, Egypt, Ismailia, 41111, Egypt
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 17/01/2019 Uploading the ethical approval TRUE, Research Ethics Committee faculty of medicine Suez Canal University, Ring Road, Ismailia, 41111, Egypt, , 06 Apr 2016, +20643200789, rec@med.suez.edu.eg, TRUE, Research Ethics Committee faculty of medicine Suez Canal University, Ring Road, Ismailia, 41111, Egypt, , 06 Apr 2016, +20643200789, rec@med.suez.edu.eg, 5831_4134_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/01/2019 the study included 136 eyes of 68 subjects divided into 2 groups each one is 68 eyes Control Group, Lasik For hyperpic patients with use of Mitomycin C, , No use of Mitomycin C at all in this group, Lasik for Hyperopic patients was done only without Mitomycin C, 68, Active-Treatment of Control Group Control Group, Lasik For hyperpic patients with use of Mitomycin C, , No use of Mitomycin C at all in this group, Lasik for Hyperopic patients was done only without Mitomycin C the group includes 68 eyes of 34 subjects, 68, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 17/01/2019 complete self funded data Self funded, Ring Road, Ismailia, 41111, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 17/01/2019 Adding Collaborators Ehab mohamed Mowad, Ring road, Ismailia, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 17/01/2019 Adding collaborators Osama Elbassiouny, Ring road, Ismailia, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 17/01/2019 Adding Collaboratrs Mohsen Saad Badawy, Ring road, Ismailia, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 17/01/2019 Adding Collaborators Amr Abdelfattah Gaballah, Ring road, Ismailia, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results summary 17/01/2019 providing Data Better predictability was noted in group A than in group B at the 6 month and 12 month follow-up visits, with a mean cycloplegic refraction SE of +0.5 ± 0.31 D in group A and +0.67 ± 0.39 D in group B at the 6 month visit, and +0.63 ± 0.37 D in group A and +0.89 ± 0.48 D in group B at the 12 month visit. The efficacy of the treatment at the end of the follow up period was better in group A than in group B. Group A showed fewer topographic corneal changes than group B.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of results summaries 17/01/2019 Providing Data 17 Jan 2019
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 17/01/2019 Providing Data 17 Jan 2019
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 17/01/2019 Providing Data still not published
Section Name Field Name Date Reason Old Value Updated Value
Reporting Baseline characteristics 17/01/2019 Providing Data This study involved 47% male and 53% female patients. Specifically, 68 eyes of 34 patients were involved in group A, where 44.1% were male patients and 55.9% were female patients, and 68 eyes of 34 patients were involved in group B, where 52.9% were male patients and 47.1% were female patients. The mean age of the study populations was 35.7 ± 11.3 years of age for group A and 34 ± 10.7 years of age for group B.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow 17/01/2019 Providing Data The preoperative CDVA was 0.96 ± 0.08 in group A and 0.95 ± 0.07 in group B. The refraction was +3.2 ± 1.1 D in group A and + 3.3 ± 1 D in group B. Keratometry was 42 ± 1.5 D in group A and 41.6 ± 1.5 D in group B. The mean corneal thickness (at the 6-mm optical zone) was 553.8 ± 11.8 µm in group A and 551.3 ± 11.5 µm in group B.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Adverse events 17/01/2019 Providing Data No recorded adverse events
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measures description 17/01/2019 Providing Data Refraction and Keratometry Changes Are The Main Outcomes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 17/01/2019 Providing Data still not published
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measure document 17/01/2019 Providing Data 5831_1327_4738.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 17/01/2019 Providing Data of results No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 28/01/2019 Changed to No as Undecided removed from list at request from WHO Undecided No
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 29/01/2019 correction Self funded, Ring Road, Ismailia, 41111, Egypt, Self Funded, Ahmed A Abdelghany, Ring Road, Ismailia, 41111, Egypt, Self Funded,