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.: PACTR202311888706058 Date of Approval: 10/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Temporary conjunctival flap for high risk fungal keratitis
Official scientific title Temporary conjunctival flap for high risk fungal keratitis
Brief summary describing the background and objectives of the trial Fungal keratitis is endemic in tropical regions, accounting for as many as half of all corneal ulcers. Since fungal keratitis carry a poor prognosis with deep stromal infection and high risk of perforation that necessitate therapeutic penetrating keratoplasty with its complication . Temporary conjunctival flap may increase the healing and decrease the perforation and the need for therapeutic keratoplasty of high risk fungal keratitis when combined with topical Natamycine and oral voriconazole Aim of the work: The aim of our study is to evaluate the efficacy and safety of temporary conjnctival flap with topical natamycine and oral voriconazole for treatment of high risk fungal keratitis . Objectives: Primary : • To Determine the perforation rate in both groups Secondary : • To detect final BCVA at 3 months • To detect microbiologic cure at 3 wks compared to the baseline • To measure the size of corneal infiltrate and/or scar size at 3 weeks and 3 months . • To measure time to re-epithelialization in both groups
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Infections and Infestations
Sub-Disease(s) or condition(s) being studied fungal keratitis
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/02/2023
Actual trial start date 07/02/2023
Anticipated date of last follow up 01/06/2023
Actual Last follow-up date 02/08/2023
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants)
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 created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group medical treatment for fungal keratitis patients will be treated with topical natamycin 5% (preserved with benzalkonium chloride, 0.01%) 1 drop applied to the affected eye every 1 hour while awake for 1 week, then every 2 hours while awake until 3 weeks from enrollment + oral voriconazole will be given in a loading dose of 400 mg twice daily for 24 hours and then a maintenance dose of 200 mg twice daily for 3 wks 3 weeks patients will be treated with topical natamycin 5% (preserved with benzalkonium chloride, 0.01%) 1 drop applied to the affected eye every 1 hour while awake for 1 week, then every 2 hours while awake until 3 weeks from enrollment + oral voriconazole will be given in a loading dose of 400 mg twice daily for 24 hours and then a maintenance dose of 200 mg twice daily for 3 wks 23 Active-Treatment of Control Group
Experimental Group temporary conjunctival flab for high risk fungal keratitis patients will be treated with topical natamycin 5% (preserved with benzalkonium chloride, 0.01%) with dosing schedules will be identical in both groups and consisted of 1 drop applied to the affected eye every 1 hour while awake for 1 week, then every 2 hours while awake until 3 weeks from enrollment + oral voriconazole will be given in a loading dose of 400 mg twice daily for 24 hours and then a maintenance dose of 200 mg twice daily for 3 weeks . plus temporary conjunctival flap at time of admission and removal after 2 weeks. 3 weeks patients at time of admission will undergo temporary conjunctival flab. Surgery will be performed in a sterile surgical room with the patient lying in supine position under an operating microscope under general anesthesia . The surgeon will remove the corneal epithelium and any necrotic tissue from the ulcerated cornea or within 0.5-1 mm of the ulcer margin. The surgeon will select a conjunctival segment close to the ulcer that exhibited the best blood supply to the corneal ulcer. A 1 ml subconjunc¬tival injection of balanced 2% lidocaine with 1:100,000 epineph¬rine will be administered to help separate the conjunctiva from the underlying Tenon's capsule . Blunt tipped scissors and blunt forceps will be used to hold the conjunctiva while the surgical blade used to make a tongue shaped incision in the quadrant of the conjunctiva near the ulcerated region. Only a partial segment of the conjunctiva will be mobilized on the ulcerated part of the cornea. After setting the conjunctival segment in place, a 10 0 monofilament nylon suture will be used to secure the flap in the cornea using interrupted sutures. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-patients with fungal keratitis and positive direct smear 2-high risk of perforation Deep a-involving post 1/3 of corneal stroma ) b-the size of ulcer more than 6 mm c- presence of hypoyon 1-Superficial small corneal ulcer 2-Previous conjunctival flap or amniotic membrane graft 3-perforated ulcer 4-Mixed infections Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 07/02/2023 Zagazig university Faculty of medicine institutional review board
Ethics Committee Address
Street address City Postal code Country
Rd inside Zagazig University, Shaibet an Nakareyah, Zagazig, Ash Sharqia Governorate Zagazig 44519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Determine the perforation rate in both groups 3 months till perforation or re epithelialization, with recording BCVA at 3 weeks and 3 months
Secondary Outcome • To detect final BCVA at 3 months • To detect microbiologic cure at 3 wks compared to the baseline • To measure the size of corneal infiltrate and/or scar size at 3 weeks and 3 months . • To measure time to re-epithelialization in both groups 3 months till perforation or re epithelialization, with recording BCVA at 3 weeks and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Zagazig university hospital Koliat Al Tob St, Shaibet an Nakareyah, Markaz El-Zakazik, Ash Sharqia Governorate Zakazik 44519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
zagazig university shaibet an Nakareyah, zagazig zagazig 44519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor zagazig university shaibet an Nakareyah, zagazig zagazig 44519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Saeed Abdelrazik alqwmia square, Zagazig, Sharkia, Egypt Zagazig 44519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Ali Goda Mohamed AGMohammed@medicine.zu.edu.eg 2001149880064 Ahmed Ghazali street, Alqawmia, Zagazig, Sharkia, Egypt
City Postal code Country Position/Affiliation
Zagazig 44591 Egypt lecturer of ophthalmology Faculty of medicine. Zagazig university
Role Name Email Phone Street address
Principal Investigator Ahmed Saeed Abdelrazik ASKhalil@medicine.zu.edu.eg 201022440775 Al Noumrosy ST Qawmia Sq.Zagazig Asharkia gov.
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Assistant professor of ophthalmology faculty of medicine Zagazig university
Role Name Email Phone Street address
Public Enquiries Marwa Ahmed Khairy marwakhairy@medicine.zu.edu.eg 0201111801956 Alqwmia Sq. Zagazig Ash Sharkia gov
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt lecturer of ophthalmology faculty of medicine Zagazig university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD underlying the results (texts, tables, figures and appendices)will be available after deidentification and will be available for data metanalysis Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
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