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.: PACTR202302902720138 Date of Approval: 15/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MANAGEMENT OF PRIMARY PTERYGIUM: EVALUATING THE COMPARATIVE EFFICACY AND SHORT-TERM OUTCOMES OF INTRALESIONAL MITOMYCIN C TO INTRALESIONAL INTERFERON ALPHA-2B AT THE EYE CLINIC OF LAGOS STATE UNIVERSITY TEACHING HOSPITAL, IKEJA
Official scientific title MANAGEMENT OF PRIMARY PTERYGIUM: EVALUATING THE COMPARATIVE EFFICACY AND SHORT-TERM OUTCOMES OF INTRALESIONAL MITOMYCIN C TO INTRALESIONAL INTERFERON ALPHA-2B AT THE EYE CLINIC OF LAGOS STATE UNIVERSITY TEACHING HOSPITAL, IKEJA
Brief summary describing the background and objectives of the trial Pterygium is a fibrovascular proliferation of degenerative conjunctiva with growth across the limbus, that may eventually encroach on the visual axis causing severe visual impairment or blindness. Surgery is the traditional modality of treatment of pterygium, usually offered when there is significant astigmatism, recurrent inflammation, cosmetic concerns or when the visual axis is threatened/obscured. Not many patients are open to surgery, and many patients default only to return with severe visual impairment or blindness from visual axis obscuration. Studies have found intralesional injections of agents such as mitomycin C (MMC), and anti-vascular endothelial growth factor (anti-VEGF) used alone or in combination with 5-fluorouracil (5-FU) for primary pterygium leads to regression, obviating the need to operate over 80% of eyes studied and significantly reducing the recurrence rates for those eyes that still required surgery. Mitomycin C in high doses is potentially toxic to the eyes. Interferon alpha-2b was found to be safer and equally efficacious in studies comparing it to mitomycin C in the management of ocular surface squamous neoplasia (OSSN). Topical interferon alpha-2b has also been used to reduce recurrence rates in up to 90% of eyes following surgical excision of pterygium. This study is a randomized control trial (RCT) to compare the efficacy and safety profile of low-dose mitomycin C to interferon alpha-2b given intralesionally in primary pterygium.
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: Drugs
Anticipated trial start date 20/02/2023
Actual trial start date
Anticipated date of last follow up 19/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intralesional mitomycin C in grades 1 and 2 primary pterygium 0.1 ml of 0.2 mg/ml of mitomycin C; Single dose 3months Intralesional injection of 0.1 ml of 0.2 mg/ml of mitomycin C given subconjunctivally, injected into the body of the pterygium, about 1mm from the corneal limbus. 50 Active-Treatment of Control Group
Experimental Group Intralesional injection of interferon alpha2b in grades 1 and 2 primary pterygium 0.1ml of 3 million international units/ml (MIU/ml); Single dose 3months Intralesional injection of 0.1ml of 3 million international units/ml (MIU/ml) of interferon alpha-2b, given subconjunctivally, and injected into the body of the pterygium, 1mm from the corneal limbus. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with grades 1 and 2 primary pterygia who present to the eye clinic of LASUTH within the period of study. 2. Consenting patients 3. Patients above 18 years (legal age for consent in Nigeria) 1. Patients with recurrent pterygium. 2. Patients with a history of corneal trauma, ulcer or corneal surgery. 3. Patients with bipolar pterygium. 4. Pregnant and lactating patients. 5. Patients with a visual impairment from other causes e.g., cataracts, glaucoma. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 LASUTH HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
1-5, Oba Akinjobi road, Ikeja, Lagos Lagos 21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in size of pterygium 2 weeks, 6 weeks and 3 months
Secondary Outcome Reduction in vascularization 2 weeks, 6 weeks and 3 months
Secondary Outcome Improvement in refraction and keratometry 2 weeks, 6 weeks and 3 months
Secondary Outcome Improvement/resolution of dry eye symptoms 2 weeks, 6 weeks and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital Eye clinic 1-5 Oba Akinjobi street, Ikeja GRA Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Fashola Maryam 1-5 Oba Akinjobi road, Ikeja Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Maryam Fashola 1-5 Oba Akinjobi road, Ikeja Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maryam Fashola maryambo02@gmail.com +2348033648954 1-5 Oba Akinjobi road, Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Registrar Ophthalmology National Postgraduate Medical College of Nigeria
Role Name Email Phone Street address
Public Enquiries Maryam Fashola maryambo02@gmail.com +2348033648954 1-5 Oba Akinjobi road, Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Registrar Ophthalmology National Postgraduate Medical college of Nigeria
Role Name Email Phone Street address
Scientific Enquiries Maryam Fashola maryambo02@gmail.com +2348033648954 1-5 Oba Akinjobi road, Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Registrar Ophthalmology National Postgraduate Medical College of Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All information collected from participants and about participants in this study will be given code numbers, and no name or personal identifiers will be recorded. This information will be routinely available to me and my immediate supervisors. Authorized representatives of the Ethics committee or the hospital regulatory board may review available records for monitoring/auditing. Results will also be made available to the larger scientific public. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1year 6months Open
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