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.: PACTR202602897516823 Date of Registration: 26/02/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mitomycin C Intravascular Chemoembolization (MICE) versus Fine Needle Diathermy (FND) for the Treatment of Corneal Neovascularization: A Comparative Study.
Official scientific title Mitomycin C Intravascular Chemoembolization versus Fine Needle Diathermy for the Treatment of Corneal Neovascularization: A Comparative Study.
Brief summary describing the background and objectives of the trial Corneal neovascularization (CN) poses a significant challenge in ophthalmic practice, often leading to compromised visual acuity , increased risk of corneal complications and reduction in the success rate of corneal graft. Despite the availability of various treatment modalities , there remains a lack of consensus regarding the optimal approach for managing CN. Conducting a prospective comparative study between MICE and FND allows a direct head-to-head comparison of these two treatment modalities, providing robust evidence to guide clinical decision-making and identifying the superior modality in terms of efficacy and safety can inform evidence-based guidelines and protocols for CN management , ultimately enhancing patient care and visual outcomes. The aim of this study is to compare the outcomes of Mitomycin C Intravascular Chemoembolization (MICE) and Fine Needle Diathermy (FND) for the Treatment of Corneal Neovascularization
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: Surgery
Anticipated trial start date 01/10/2024
Actual trial start date 01/10/2025
Anticipated date of last follow up 01/11/2025
Actual Last follow-up date 01/12/2025
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
614 29 Sep 2024 Instituitional Review Board, Faculty of Medicine, Zagazig University
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
Experimental Group Mitomycin C Intravascular Chemoembolization 0.01 to 0.05 ml of Mitomycin C (0.4 mg/mL) injected intraoperatively single intraoperative dose A 1.0 cc syringe partially filled with Mitomycin C (0.4 mg/mL) and attached to a 33-gauge needle enters the largest bore corneal vessel just inside the limbus with the needle angled at approximately 15 degrees from the corneal surface to cannulate the vessel. A small volume of Mitomycin C (0.01 to 0.05 ml) is injected with enough retrograde hydrostatic force to fill both the efferent and afferent vessels. 19
Control Group Fine Needle Diathermy single intraoperative intervention single intraoperative intervention A 10–0 nylon suture needle is inserted 0.5 to 1 mm from the limbus and passed parallel to and at the same depth as the blood vessels to be occluded.The probe of unipolar diathermy unit at low setting coagulation mode is applied to the needle for 1 to 2 seconds until the corneal stroma is whitened. 19 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18-70 years Corneal neovascularization due to trauma, infection or lipid keratopathy History of previous interventions for corneal neovascularization Presence of active ocular infection or inflammation. Concurrent ocular or systemic diseases affecting corneal integrity or healing Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 29/09/2024 Institutional Review Board Faculty of Medicine Zagazig University
Ethics Committee Address
Street address City Postal code Country
Koliat Altob street Zagazig 44519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in neovascularization area 1 week, 1 month, 3 month, 6 month postintervention
Primary Outcome Best Corrected Visual Acuity 1 week, 1 month, 3 month, 6 month postintervention
Secondary Outcome Postoperative complications 1 week, 1 month, 3 month, 6 month postintervention
Secondary Outcome Recurrence of neovascularization 1 week, 1 month, 3 month, 6 month postintervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Zagazig University Hospitals Koliat Altob street Zagazig 44519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Reem Dessouky 27 Osman bin Affan street Zagazig Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Reem Dessouky 27 Osman bin Affan street Zagazig Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
AbdulRahman Ali Thabit Hassan Alkawmeya Zagazig Egypt
AlSadek Abdelaziz Suliman Maali Fakous Zagazig Egypt
Ali Goda Ali Mohamed Alkawmeya Zagazig Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AbdulRahman Ali Thabit Hassan aa.hasan24@medicine.zu.edu.eg +201140401157 Alkawmeya
City Postal code Country Position/Affiliation
Zagazig Egypt Zagazig University
Role Name Email Phone Street address
Scientific Enquiries Ali Goda Ali Mohamed AGMohammed@medicine.zu.edu.eg +201149880064 Alkawmeya
City Postal code Country Position/Affiliation
Zagazig Egypt Zagazig University
Role Name Email Phone Street address
Public Enquiries Reem Dessouky reem.amir@medicine.zu.edu.eg +201227297952 27 Osman bin Affan street
City Postal code Country Position/Affiliation
Zagazig Egypt Assistant Professor of Ophthalmology Zagazig University
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) Statistical Analysis Plan 1 year after publication of the study results researchers who provide a methodologically sound proposal
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 18/02/2026 the aim of the study has been added Corneal neovascularization (CN) poses a significant challenge in ophthalmic practice, often leading to compromised visual acuity , increased risk of corneal complications and reduction in the success rate of corneal graft. Despite the availability of various treatment modalities , there remains a lack of consensus regarding the optimal approach for managing CN . Conducting a prospective comparative study between MICE and FND allows a direct head-to-head comparison of these two treatment modalities, providing robust evidence to guide clinical decision-making and identifying the superior modality in terms of efficacy and safety can inform evidence-based guidelines and protocols for CN management , ultimately enhancing patient care and visual outcomes. Corneal neovascularization (CN) poses a significant challenge in ophthalmic practice, often leading to compromised visual acuity , increased risk of corneal complications and reduction in the success rate of corneal graft. Despite the availability of various treatment modalities , there remains a lack of consensus regarding the optimal approach for managing CN. Conducting a prospective comparative study between MICE and FND allows a direct head-to-head comparison of these two treatment modalities, providing robust evidence to guide clinical decision-making and identifying the superior modality in terms of efficacy and safety can inform evidence-based guidelines and protocols for CN management , ultimately enhancing patient care and visual outcomes. The aim of this study is to compare the outcomes of Mitomycin C Intravascular Chemoembolization (MICE) and Fine Needle Diathermy (FND) for the Treatment of Corneal Neovascularization
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 18/02/2026 minimum age has been included Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/02/2026 postintervention has been clarified Primary Outcome, Reduction in neovascularization area, 1 week, 1 month, 3 month, 6 month Primary Outcome, Reduction in neovascularization area, 1 week, 1 month, 3 month, 6 month postintervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/02/2026 postintervention has been clarified Primary Outcome, Best Corrected Visual Acuity, 1 week, 1 month, 3 month, 6 month Primary Outcome, Best Corrected Visual Acuity, 1 week, 1 month, 3 month, 6 month postintervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/02/2026 postintervention has been clarified Secondary Outcome, Postoperative complications, 1 week, 1 month, 3 month, 6 month Secondary Outcome, Postoperative complications, 1 week, 1 month, 3 month, 6 month postintervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/02/2026 postintervention has been clarified Secondary Outcome, Recurrence of neovascularization, 1 week, 1 month, 3 month, 6 month Secondary Outcome, Recurrence of neovascularization, 1 week, 1 month, 3 month, 6 month postintervention
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 18/02/2026 IPD statement has been clarified preoperative and postoperative individual participant data from which the statistical analysis was performed that underlie the results reported in the article Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures and appendices)