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.: PACTR202508688024923 Date of Registration: 14/08/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Aspheric Monofocal IOLs and Contrast Sensitivity
Official scientific title Comparison of Aberration-Correcting versus Aberration -Neutral Aspheric Monofocal Intraocular Lenses in Improving Contrast Sensitivity for Post LASIK Cataract Patients in Ismailia, Egypt: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Background: Cataract is considered as the first cause worldwide of reversible blindness. With advances in technology and the rise in patients’ postoperative expectations, cataract surgery becomes a refractive procedure which carries a refractive target. Higher order aberrations (HOAs) are the main factor which is directly related to the quality of vision. Cornea is responsible for 98% of HOAs. Corneal spherical aberrations (SA) are directly related to contrast sensitivity. Correcting corneal SA using aspheric IOLs increases contrast sensitivity, quality of vision and postoperative patient satisfaction. Objective: To assess the contrast sensitivity and ocular high order aberrations before and after phacoemulsification for post LASIK cataract patients using aberration correcting aspheric monofocal intraocular lenses (IOLs) versus aberration neutral IOLs.
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 01/09/2025
Actual trial start date 01/09/2025
Anticipated date of last follow up 30/09/2025
Actual Last follow-up date 31/10/2025
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 64
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Phacoemulsification and intraocular lens implantation No drugs used One month Experimental group: Phacoemulsification and intraocular lens implantation using aspheric monofocal aberration neutral IOLs 32 Active-Treatment of Control Group
Experimental Group Phacoemulsification and intraocular lens implantation No drugs used One month Phacoemulsification and intraocular lens implantation using aspheric monofocal aberration correcting IOLs. 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients will be enrolled in the study if they are: • Older than 40 years old, • With prior LASIK refractive surgery and • Having age-related cataract. Patients with any of the following will be excluded from the study: • History of previous ocular surgery • Prior intraocular inflammation, such as uveitis. • History of either blunt or penetrating ocular trauma. • Corneal opacity, dystrophy or degenerations. • Increased intraocular pressure over 21 mmHg. • Endothelial cell count, less than 2000 cells/mm2. • Retinal or optic nerve disease. • Intraoperative complications, such as posterior capsule rupture and postoperative complications. • Congenital cataract, secondary cataract or cataract associated with systemic diseases such as diabetes mellitus • No health insurance coverage. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 75 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 22/07/2025 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Kilo 4.5, Ring Road, Ismailia, Egypt Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome contrast sensitivity measurement Preoperatively and one month postoperative
Secondary Outcome corneal spherical aberrations, high order aberration, point spread function and visual acuity. Preoperatively and one month postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospital Kilo 4.5 ring road Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moataz A Sallam Kilo 4.54 ring road Ismailia Egypt 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Hospitals Kilo 4.5 ring road Ismailia 41111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moataz Sallam moataz.sallam@med.suez.edu.eg 00201111113588 Kilo 4.5, Ring Road
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Associate Professor. Ophthalmology Consultant. MD. FRCSGlasg. Suez Canal University Hospital
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mounir mohamedmounir@med.suez.edu.eg 0020110907077 Kilo 4.50, Ring Road
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt MD. Ophthalmology Consultant at Suez Canal University Hospital
Role Name Email Phone Street address
Public Enquiries Moataz Sallam moataz.sallam@med.suez.edu.eg 00201111113588 Kilo 4.5, Ring Road
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Associate Professor. Ophthalmology Consultant. Md. FRCSGlasg. Suez Canal University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data that underlie the results reported in this article after deidentification. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months following article publication. Proposals should be directed to moataz.sallam@med.suez.edu.eg. Then the request will be introduced to Our University admins for approval. Data will be replied through the principal investigator
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/08/2025 Modification after reviewing Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 08/08/2025 Clear legible letter TRUE, Research Ethics Committee Faculty of Medicine Suez Canal University, Kilo 4.5, Ring Road, Ismailia, Egypt, Ismailia, 41522, Egypt, , 22 Jul 2025, 0020643200789, rec@med.suez.edu.eg, 35995_33164_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 08/08/2025 Data completion Authors, Kilo 4.54 ring road, Ismailia Egypt, 41111, El Salvador, Self Funded, Moataz A Sallam Mohamed M Ali Waleed A Ghobashy, Kilo 4.54 ring road, Ismailia Egypt, 41111, El Salvador, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 08/08/2025 Data completion Moataz A Sallam Mohamed M Ali Waleed A Ghobashy, Kilo 4.54 ring road, Ismailia Egypt, 41111, El Salvador, Self Funded, Primary investigator, Kilo 4.54 ring road, Ismailia Egypt, 41111, El Salvador, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 08/08/2025 Data completion Primary investigator, Kilo 4.54 ring road, Ismailia Egypt, 41111, El Salvador, Self Funded, Principal investigator Moataz A Sallam, Kilo 4.54 ring road, Ismailia Egypt, 41111, El Salvador, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 08/08/2025 Data completion Principal investigator Moataz A Sallam, Kilo 4.54 ring road, Ismailia Egypt, 41111, El Salvador, Self Funded, Principal investigator Moataz A Sallam, Kilo 4.54 ring road, Ismailia Egypt, 41522, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 14/08/2025 PACTR Admin Principal investigator Moataz A Sallam, Kilo 4.54 ring road, Ismailia Egypt, 41522, Egypt, Self Funded, Moataz A Sallam, Kilo 4.54 ring road, Ismailia Egypt, 41522, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 08/08/2025 Data completion Available upon reasonable request Individual participants data that underlie the results reported in this article after deidentification.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/08/2025 Data completion Available upon reasonable request Beginning 9 months and ending 36 months following article publication.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 08/08/2025 Data completion Available upon reasonable request Proposals should be directed to moataz.sallam@med.suez.edu.eg. Then the request will be introduced to Our University admins for approval. Data will be replied through the principal investigator
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 08/08/2025 Data completion Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code