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.: PACTR202009674896369 Date of Approval: 28/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Double Folded “Taco” Corneal Flap in LASIK Correction of Hyperopia
Official scientific title Double Folded “Taco” Corneal Flap in LASIK Correction of Hyperopia
Brief summary describing the background and objectives of the trial The surgical treatment of hyperopia has never enjoyed the widespread popularity and acceptance among patients or Ophthalmologist that PRK, and LASIK for myopia have achieved. Application of laser ablation at the mid-periphery of the corneal stroma near to the flap edge in hyperopic LASIK increases the risk of intraoperative corneal epithelial injuries, flap dislocation and postoperative epithelial ingrowth incidence that eventually affect visual recovery. Regardless the method used to create the flap either microkeratome or femtosecond laser assisted, It is important to secure the flap while performing the laser ablation. Reflecting the flap makes the underside (stromal face) exposed during ablation for both debris and even pannus-related blood staining. In addition, when correcting hyperopia, the treatment zone may exceed the flap diameter, and laser may evaporate the underside of the hinge with subsequent unstable flap, and delayed visual recovery. This study aims to assess the novel double folded “Taco” corneal flap during hyperopic LASIK correction regarding accidental flap ablation, under surface debris, epithelial ingrowth and visual recovery over a one-month follow-up period. STUDY OBJECTIVES: 1. To compare both double folded “Taco” corneal flap and reflected upon flap regarding flap protection from accidental ablation, under surface debris, and visual recovery during hyperopic-LASIK correction. 2. To assess predictability and safety of treatment after hyperopic-LASIK correction
Type of trial CCT
Acronym (If the trial has an acronym then please provide) LASIK
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 12/03/2020
Actual trial start date
Anticipated date of last follow up 25/04/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
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
Parallel: different groups receive different interventions at same time 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 Double folded flap right eye conventional flayed flap left eye not applicable 10 minutes 1- Topical Anesthesia: Benoxinate hydrochloride eye drops 0.4% , 2 drops will be instilled in the conjunctival sac 1 minute before the procedure. 2- Moria 2 microkeratomes (Moria, Antony, France) will be used to create the corneal flaps. Superiorly hinged corneal flaps will be created using a suction ring and 130-μm microkeratome depth plate. 3- Schwind Amaris-500 E Excimer laser machine will be used to perform the corneal stromal ablation and a 6.0-mm optical zone (with a peripheral transition zone of 9 mm) was programmed in all cases. 4- In group A (right eyes) double folded “Taco” corneal flaps will be created; then Spatula will inserted under the middle of the flap, drag it that underside of upper half of the flap sticks to underside of the lower part of the flap in taco-shape then to be flayed on superior bulbar conjunctiva. 12
Control Group Conventional flayed flap during Hyperopic LASIK not applicable 10 minutes 1- Topical Anesthesia: Benoxinate hydrochloride eye drops 0.4% , 2 drops will be instilled in the conjunctival sac 1 minute before the procedure. 2- Moria 2 microkeratomes (Moria, Antony, France) will be used to create the corneal flaps. Superiorly hinged corneal flaps will be created using a suction ring and 130-μm microkeratome depth plate. 3- Schwind Amaris-500 E Excimer laser machine will be used to perform the corneal stromal ablation and a 6.0-mm optical zone (with a peripheral transition zone of 9 mm) was programmed in all cases. 4- In group B (left eye) conventional reflected flaps will be created; Spatula will be inserted under the middle of the flap reflecting the flap then flayed on upper lid. 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Patients above 21 years (with stable refraction). 2) Patients with Hyperopia with or without astigmatism. 1) Different kind of refractive errors other than listed above. 2) Patients under recommended age or with unstable refraction. 3) Patients with systemic conditions that affects stability of refraction e.g uncontrolled diabetes, pregnancy and lactation. 4) Patients with systemic conditions that affect wound healing e.g. rheumatoid arthritis. 5) Patients with any other ocular pathology e.g. keratoconus, pellucid marginal degeneration, Foch’s corneal dystrophy, cataract and glaucoma. 6) Patients with previous refractive corneal surgeries. 7) Patients that couldn’t fulfill one year follow up. Adult: 19 Year-44 Year 21 Year(s) 45 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
No 10/03/2020 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine Suez Canal University, Ring Road Ismailia 45122 Egypt
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 28/07/2020 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Ring Road, Ismailia , EGYPT ISMAILIA 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual acuity 1st day , first week and first month
Primary Outcome Assessment of the corneal flap for healing and stability and stromal interface for debris or epithelial ingrowth. 1st day, first week and first month
Secondary Outcome Efficacy of LASIK: percentage of eyes that showed an equal or better postoperative uncorrected distance visual acuity (UDVA) after one month of LASIK correction compared to preoperative corrected distance visual acuity (CDVA). 1st week and first month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Jawhara Eye Center Shebin El Koom street , Courts ccomplex Ismailia 41525 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Waleed Ghobashy Moorfields eye hospital center Marina village Villa B01, B02 Abu Dhabi 62807 United Arab Emirates Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ehab Moawad drehab_eye@hotmail.com +201227513043 Ophthalmology department, Faculty of medicine, Suez canal university
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt Ophthalmology department Faculty of medicine Suez canal university
Role Name Email Phone Street address
Public Enquiries Waleed Ghobashy Waleed_Ghobashy@Hotmail.com +971561269356 Moorfields Eye Hospital Center Villas B01, B02, Marina village
City Postal code Country Position/Affiliation
Abu Dhabi 62807 United Arab Emirates Ophthalmology Department Faculty of medicine Suez Canal University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elsebayee meeishahin@yahoo.com +201222120579 Faculty of medicine, Suez Canal University
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt Ophthalmology Department Faculty of medicine Suez Canal University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Open access for all ophthalmologist working the the refractive surgery field
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