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.: PACTR202112812889125 Date of Approval: 24/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Amount Of Post-Operative Total Ocular Aberration And Its Correlation To The Depth of Field after Implantation of Eyhance in Phacoemulsification
Official scientific title The Amount Of Post-Operative Total Ocular Aberration And Its Correlation To The Depth of Field after Implantation of Monofocal IOL with Extended Depth of Focus in Phacoemulsification
Brief summary describing the background and objectives of the trial A new monofocal IOL with different design has become available to offer sufficient depth of focus to provide the patients with comfortable vision without impairing far vision. We aim to evaluate post-operative visual outcome by measuring the degree of total ocular aberration and maximum near point of functional vision with distance correction after implantation of the TECNIS Eyhance IOL.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) Ocular
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 04/08/2021
Actual trial start date 13/08/2021
Anticipated date of last follow up 04/09/2021
Actual Last follow-up date 22/12/2021
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 34
Recruitment status Active, not recruiting
Publication URL Not used
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised 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
Experimental Group Phacoemulsification Once per eye 15 to 30 minutes Phacoemulsification is an ocular surgery to remove cataractous lens to be replaced by the monofocal foldable intraocular lens with extended depth of focus 17
Control Group Phacoemulsification Once 15 to 30 minutes Phacoemulsification to emulsify cataractous crystalline lens and replaced by the usual foldable intraocular lens 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with senile cataract scheduled for implantation with TECNIS® Eyhance 2. Age 40 and older 3. Clear intraocular media 4. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures 1. Visual potential of less than 0.63 in each eye due to ocular pathologies, e.g retinal disorders 2. Corneal astigmatism over 1D cylinder 3. Use of systemic or ocular medication that might affect vision 4. Acute or chronic disease, illness, ocular trauma or surgery that would confound results (e.g. macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma etc.) 5. Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus 6. Capsule or zonular abnormalities that affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) 7. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions) 8. Patients who underwent refractive eye surgery (LASIK, PRK) or corneal crosslinking. 9. Intraoperative complications (e.g. posterior capsular tear or zonular dialysis, eccentric capsulorrhexis). 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 08/03/2021 Kasr El Ainy ophthalmology department
Ethics Committee Address
Street address City Postal code Country
Kasr El Ainy Street - Cairo Cairo 11311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Spherical aberration measurement after implantation of monofocal IOL with extended depth of focus 2- Uncorrected monocular distance visual acuity 3- Uncorrected binocular distance, intermediate and near visual acuity. After 3 weeks
Secondary Outcome Corrected monocular and binocular distance visual acuity Corrected binocular intermediate and near visual acuity 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar Eloyon ophthalmology hospital Entrance 2- Sheikh Zayed City- Dorra Square Cairo 12588 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding Elzemrany Street Albuhairah Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Been El Sarayat street Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohammed Hosny mohamedhosny@mac.com 00201000007675 Kasr El Ainy Street
City Postal code Country Position/Affiliation
Giza Egypt Professor Doctor at Ophthalmology Department of Kasr El Ainy Hospitals
Role Name Email Phone Street address
Principal Investigator Mohammed Abd Elghaffar Shehata Mohamedabdelghafar113@gmail.com 00201003437843 El Zemrany Street
City Postal code Country Position/Affiliation
El Buhairah Egypt Ophthalmology resident in Itay Elbaroud general hospital
Role Name Email Phone Street address
Public Enquiries Mohammed Attya mohamed.attya86@yahoo.com 00201068277133 Qasr Al Ainy hospital
City Postal code Country Position/Affiliation
Giza Egypt Ophthalmology lecturer in Qasr Al Ainy hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be shared once we obtain results for anyone who wishes to access the data for any purpose Study protocol will be available Study Protocol 6 months Study protocol Study address
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not used 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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be shared once we obtain results for anyone who wishes to access the data for any purpose Study protocol will be available Study Protocol 6 months Study protocol Study address
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not used 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