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.: PACTR202003505327916 Date of Registration: 20/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Corneal haze and densitometry in Keratoconus Post-collagen Cross-Linking by three different protocols
Official scientific title Corneal haze and densitometry in Keratoconus Post-collagen Cross-Linking by three different protocols
Brief summary describing the background and objectives of the trial Progressive keratoconus (KC) and divided into three groups. Group (I) was exposed to standard CXL, group (II) to trans-epithelial CXL, and group (III) to the accelerated CXL (10 mW/cm2 for 9 minutes). Subjective and objective corneal haze was evaluated before CXL, 3, 6, and 12 months postoperatively using slit-lamp biomicroscopy and pentacam.
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 Diagnosis / Prognosis
Anticipated trial start date 01/01/2017
Actual trial start date 17/02/2017
Anticipated date of last follow up 02/09/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 104
Recruitment status Closed to recruitment,follow-up continuing
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 from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TECXL 2 y In Group II, trans-epithelial CXL (TE-CXL) was applied. Riboflavin (Ricrolin TE, Sooft, Italy) was used on an intact corneal epithelium without any disruption. Riboflavin was placed, two drops every 5 minutes for 30 minutes. The rest of the procedure and irradiation technique was accomplished as in the group I 34
Experimental Group ACCXL 2 y In group III (accelerated CXL), after the mechanical removal of the epithelium within the central 8 mm, riboflavin (Vibex Rapid, Avedro, USA) was applied to the corneal surface every 2 minutes for 10 minutes. Then, UVA irradiation for 9 minutes using an irradiation UVA device (CBM Vega 10 mW X-Linker, Firenze, Italy) was accomplished. The other sequential steps were as in group I. Table (1) displays the parameters of UVA irradiation systems and riboflavin solutions used in the three groups. 34
Control Group SCXL 2 y In Group I, the standard CXL (S-CXL) protocol was designed. The corneal epithelium was scraped from the central 8 mm via the surgical blade. Every 3 minutes, one drop of Riboflavin solution 0.1% (Ricrolin, Sooft, Italy) was applied to the corneal surface for half an hour. Then it's followed by the exposing the corneal surface to ultraviolet A (UVA) irradiation (370 nm/3 mWcm-2) for 30 minutes using (CBM X-linker, Italy) UVA system. Throughout the irradiation time, riboflavin solution was put on the corneal surface every 2 minutes. Lastly, the ocular surface was well washed by the balanced salt solution and a therapeutic contact lens was placed on the cornea until total re-epithelization. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Progressive KC grade I-III based on Amsler–Krumeich grading. Kc progression was documented through 2 or more of the following criteria: an increase in K max readings by 1 diopter ( D) an increase in the posterior k readings by 1 D an increase in spherical equivalent by  0.50 D or more. A decrease in the pachymetry of more than 2 %. Any synchronous corneal infections. Severe dryness. Corneal opacity. Advanced disease. Previous ocular surgeries. Current ocular disease as vitreoretinal disorders, glaucoma or cataract. Adult: 19 Year-44 Year 18 Year(s) 30 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 17/02/2017 Mansoura University College of Medicine Ethical committe
Ethics Committee Address
Street address City Postal code Country
25 Elgomhouria St., Mansoura City Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Haze and Optical corneal densitometry outcomes 3.6.12 months
Primary Outcome visual and refractive outcomes 3.6.12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Elgomhouria St Mansoura Egypt
Al hayat Ophthalmic hospital Elgomhouria St Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amani Badawi Elgomhouria St Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhouria St Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amani Badawi amanibadawi37@yahoo.com 00201003818271 Elgomhouria St
City Postal code Country Position/Affiliation
Mansoura Egypt Associated professor Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Maysaa El Sayed Zaki may_s65@hotmail.com 00201227185777 Elgomhouria St
City Postal code Country Position/Affiliation
Mansoura Egypt Professor of clinical pathology member of ethical committee Mansoura University
Role Name Email Phone Street address
Public Enquiries Mohammed Ahmed irb_h@hotmail.com 00201092127930 Elgomhouria St
City Postal code Country Position/Affiliation
Mansoura City Egypt Secretary and Ethics Committee official
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be allowed for sharing Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 months after the end of the study Ophthalmologists are allowed access to data. they should email the principal investigator via amanibadawi372yahoo.com to get permission after reviewing the qualifications and quality of request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The results summary will be available as a PDF including topographic, visual and refractive outcomes 30/06/2020 30/12/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/file/d/18bMvYih8grq_YVGpAqGmDw_fJry95arI/view
Changes to trial information