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.: PACTR202312829415921 Date of Approval: 05/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of choroidal thickness after corneal cross linkage in keratoconus patients
Official scientific title Evaluation of choroidal thickness after corneal cross linkage in keratoconus patients
Brief summary describing the background and objectives of the trial Background: Choroidal thickness (CT) has been found to increase significantly in patients with keratoconus (KC) compared to healthy subjects in multiple studies. A study carried upon rhesus monkey eyes found that the scleral cross-linking led to transient thinning in choroidal thickness. Objective of trial: To evaluate the choroidal thickness after corneal cross-linking in keratoconus patients.
Type of trial Observational
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 01/03/2023
Actual trial start date 01/03/2023
Anticipated date of last follow up 01/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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
Single Group 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 Corneal crosslinking 13 minutes and 40 seconds Corneal cross-linking (Accelerated Protocol): Patient’s eye will be anesthetized with topical 1% benoxinate under sterile conditions. The central 8 mm of the corneal epithelium will be removed manually. 0.1% riboflavin with hydroxypropyl methylcellulose (HPMC; VibeX Rapid, Avedro, Waltham, MA) will be applied every 2 minutes for 10 minutes. After that, the cornea will be illuminated with continuous irradiation of 30 mW/cm2 for 3 minutes and 40 seconds with KXL (Avedro). The cumulative irradiation dose will be 6.6 J/cm2 . Then, the cornea will be rinsed with balanced salt solution and 0.5% moxifloxacin will be instilled. A bandage contact lens will be applied and 0.5% moxifloxacin will be used for four days. The bandage contact lens will be removed after epithelial healing. 0.1% fluorometholone will be applied four times a day and to be tapered over a period of one month. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Clinical diagnosis of keratoconus - Age between 15 and 30 years - Systemic inflammatory diseases (e.g. collagen vascular diseases such as systemic lupus erythematosus) - High refractive errors that can potentially affect choroidal anatomy and thickness (spherical equivalent of -7 diopters (D) or more) - Presence of any ocular pathology other than KC - Post laser-assisted in situ keratomileusis ectasia - Previously cross-linked corneas - Patients with diabetes mellitus - History of ocular trauma or refractive surgery - Presence of medial opacities hindering choroidal imaging Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 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 01/03/2023 Ethics Committee of Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Elkhartoum Square, Elazaritta Alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Choroidal thickness will be measured using Spectralis SD-OCT (Heidelberg Engineering, Heidelberg, Germany) with an enhanced depth imaging (EDI) configuration. The choroidal thickness will be measured manually by the examiner on the fundus image that is captured using EDI SD-OCT from the choroidal-scleral junction to the outer edge of the retinal pigment epithelium (RPE). The measurements will be taken at subfoveal choroid (SC) and at 1000 um from the fovea, including nasal choroid at 1000 um (NC1000), temporal choroid at 1000 um (TC1000), inferior choroid at 1000 um (IC1000) and superior choroid at 1000 um (SC1000). one month and three months post-operatively
Secondary Outcome Choroidal thickness will be measured using Spectralis SD-OCT (Heidelberg Engineering, Heidelberg, Germany) with an enhanced depth imaging (EDI) configuration. The choroidal thickness will be measured manually by the examiner on the fundus image that is captured using EDI SD-OCT from the choroidal-scleral junction to the outer edge of the retinal pigment epithelium (RPE). The measurements will be taken at subfoveal choroid (SC) and at 1000 um from the fovea, including nasal choroid at 1000 um (NC1000), temporal choroid at 1000 um (TC1000), inferior choroid at 1000 um (IC1000) and superior choroid at 1000 um (SC1000). One month and three months post-operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Main University Hospital Khartoum square Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria Main University Hospital Elkhartoum Square, Elazarita Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Main University Hospital Elkhartoum square, Elazzaritta Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof Dr Ahmed Elmassry 398 Horreya Street, Mustafa kamel. Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elmassry ahmad.elmassry@gmail.com +201222152435 398 Horreya Street, Mustafa Kamel
City Postal code Country Position/Affiliation
Alexandria Egypt Professor
Role Name Email Phone Street address
Scientific Enquiries Ahmed Hussein a_ragab12@alexmed.edu.eg +201113238786 Elkhartoum square, Elazaritta
City Postal code Country Position/Affiliation
Alexandria Egypt Consultant
Role Name Email Phone Street address
Public Enquiries Monsef Kharboush mfik358@gmail.com +201223327639 Elkhartoum square, Elazaritta
City Postal code Country Position/Affiliation
Alexandria Egypt Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol 2 years Open access
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