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.: PACTR202106741373163 Date of Approval: 07/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Alexandria Study I - Demonstration of Safety and Efficacy of the EYEPCR RING with Senile (Age Related) cataract
Official scientific title Alexandria Study I - Demonstration of Safety and Efficacy of the EYEPCR RING with Senile (Age Related) cataract
Brief summary describing the background and objectives of the trial The present study is intended to demonstrate the safety and efficacy of the EYEPCR ring, hereafter mentioned as CR1 ring. The investigational device is designed to expand and reshape the capsule of the human eye after phacoemulsification ensuring the restoration of its natural shape. Also it is intended to serve as an IOL holder and stabilization device maximizing the precision of the desired refracting outcome. The CR1 ring is implanted in the lens capsule during cataract surgery and prior to Intraocular lens implantation. The device is foldable and injected via a suitable injector through the primary corneal wound. After implantation the device expands to its original annular shape that restores the natural shape of the peripheral capsule and serves as a stable holder for IOL implantation. The expanded CR1 Ring occupies the space in the peripheral capsule initially occupied by the natural lens. In this manner, its equator is axially coinciding with the preoperative equator. The ring in that manner ensures that the IOL is positioned centrally with respect to the crystalline lens equator but also to a more consistent axial depth. Moreover, the CR1 ring features an edged design on its posterior side near the equator that maintains circumferential contact with the posterior capsule. In this manner, it serves as a mechanical barrier for epithelial cell migration and therefore it may prevent the formation of posterior capsule opacification. The study refers to subjects with cataract who have no other ophthalmic pathologies.
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: Devices
Anticipated trial start date 21/12/2019
Actual trial start date 21/12/2019
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CR1 Implantation 1 single intervention, 1 to 2 minutes in addition to standard intervention Implantation of CR1 through a small incision after crystalline lens phacoemulsification 120
Control Group Conventional cataract surgery single intervention, about 10 minutes Conventional cataract surgery 120 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adults 2. Cataract patients classified using LOCS III Grating, Grade 1 (Nuclear), Grade 2 (Cortical) or Grade 3 (Posterior) 3. Suitable to receive a standard monofocal IOL having a power range between 15 and 25 diopters 4. 4 Clear intraocular media other than cataract 5. No previous intraocular or corneal surgery 6. No traumatic cataract 7. Stability of keratometry or biometry measurements. No indication of corneal ecstatic conditions or other corneal dystrophies 8. No irregular astigmatism 9. No pregnancy potential or lactation 10. Not concurrent participation in another drug or device investigation 11. Availability for postoperative follow up 12. Ability to sign the inform consent form 1. Dense cataract 2. Cataract patients which also have additional anterior segment ophthalmic pathology (e.g. glaucoma, pseudoexfoliation syndrome). 3. Previous corneal surgeries (LASIK, PRK, CCL, etc) 4. Monocular patient 5. Patients who are not available for post operative follow up 6. 6. Patients who cannot consent to their enrolment the study. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 100 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 19/12/2019 Ethcs Committee of Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Alexandria University, 17 Champollion Street, El Messalah, Alexandria, Egypt Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post operative Best Spectacle Corrected Visual Acuity (BSCVA), Post operative Uncorrected Visual Acuity (UCVA), Standard deviation of the refractive surprise (Intended - Achieved refraction), Intraocular lens centration and tilt. 1 day, 1 week, 1 month, 3 months, 6 months, 1 year Postoperatively
Secondary Outcome PCO incidence 1 day, 1 week, 1 month, 3 months, 6 months, 1 year Postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elnour Eye Center 398 Horeya Street Alexandria, Egypt Alexandria 21111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
EYEPCR B.V. Westerdoksdijk 423, 1013 BX Amsterdam, Netherlands Amsterdam 1013 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EYEPCR B.V. Westerdoksdijk 423. 1013 BX Amsterdam, Netherlands Amsterdam 1013 Netherlands Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elmassry ahmad.elmassry@gmail.com 1222152435 398 Horeya Street Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Head of Ophthalmology department Professor of Ophthalmology Alexandria University Egypt
Role Name Email Phone Street address
Public Enquiries Ibtesam Yakoot tantysam@yahoo.com 00201001536564 398 Horeya Street Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Assistant in Ophthalmological Clinic
Role Name Email Phone Street address
Scientific Enquiries Osama Ibrahim ibrosama@gmail.com +201222152435 Alexandria University, Egypt
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Past president of Alexandria University. Professor of Ophthalmology Faculty of Medicine. Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data of the clinical trial (with the exception of data pertaining to the European GDPR) will be shared with any competent authority associated with product evaluation and approval. Informed Consent Form,Statistical Analysis Plan,Study Protocol After completion of the 12-month follow up period. Following request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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