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.: PACTR202306903483335 Date of Approval: 23/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title COMPARATIVE EVALUATION OF USE OF FIBRIN GLUE VERSUS SUTURES FOR CONJUNCTIVAL AUTOGRAFT IN TREATMENT OF PRIMARY PTERYGIUM: IMPACT ON ASTIGMATISM, RECURRENCE, AND PATIENT SATISFACTION
Official scientific title COMPARATIVE EVALUATION OF USE OF FIBRIN GLUE VERSUS SUTURES FOR CONJUNCTIVAL AUTOGRAFT IN TREATMENT OF PRIMARY PTERYGIUM: IMPACT ON ASTIGMATISM, RECURRENCE, AND PATIENT SATISFACTION
Brief summary describing the background and objectives of the trial Background: Pterygium is an ingrowth of degenerative tissue from the bulbar conjunctiva over the limbus and unto the cornea forming a triangle shape. Surgical treatment of pterygium is often done using conjunctival autograft with suture. This method is, however, fraught with disadvantages such as increased surgical time, induced astigmatism and suture-related complications such as grittiness, discomfort, redness and pain. The use of fibrin glue has been proven to reduce these drawbacks. Aim: To compare the surgical outcome of conjunctival autograft using fibrin glue versus nylon 9.0 suture after pterygium excision with a view to making recommendations. Methods: A hospital-based randomized clinical trial will be conducted among 70 patients undergoing pterygium excision. Patients that meet the eligibility criteria will be recruited and randomized into two groups: fibrin glue group A and nylon 9.0 suture group B. The degree of astigmatism will be measured pre and post- operatively in both groups. The duration of surgery and patient satisfaction will also be measured. These findings will be compared between the groups. Also, the best corrected visual acuity and patient's discomfort will be assessed and compared. Data Analysis: Data will be analyzed with IBM-Statistical Package for Social Sciences (IBM-SPSS) version 25.0 for Windows from IBM Corp., Armonk, New York, USA. Categorical variables will be presented using frequencies and percentages. Continuous variables will be presented as Mean ± S.D. while median and interquartile will be used when skewed. Kolmogorov -Sminov test will be used to assess normal distribution. Association between categorical variables will be carried out using the Chi-square test or Fischer exact test: If the comparable number is small - Mean comparison between two means will be carried out using the Independent student t- test while Median comparison will be carried out using Man-Whitney U test. P-value <0.05 will be accepted as statistically significant at a 95% confidence interval.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 11/05/2023
Actual trial start date 11/05/2023
Anticipated date of last follow up 10/03/2024
Actual Last follow-up date 10/03/2024
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fibrin glue for conjunctival autograft folowing pterygium excision Once 6months Fibrin glue will be used for conjunctival autograft following perygium excision 35
Control Group Sutures for conjunctival autograft following pterygium excision Once 6months Sutures will be used for conjunctival autograft following pterygium excision 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Consenting patients with grade 2 and above pterygium attending the LASUTH eye clinic. 2. Consenting patients aged18 years and above. 1. Pingueculum and grade 1 pterygium. 2. Patients less than18 years with active inflammation. 3. Patients with cornea disease. 4. Previous ocular surgeries within six months of recruitment. 5. Patients with recurrent pterygium 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 11/05/2023 health research and ethics committee
Ethics Committee Address
Street address City Postal code Country
1-6 Oba Akinjobi road Ikeja GRA Ikeja PMB 21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Resolution of astigmatism 6months
Secondary Outcome Improved visual acuity, Refractive state and patient satisfaction 6months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital 1-5 Oba Akinjobi road Ikeja GRA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bernadette o Aghahon 1-6 Oba Akinjobi road Ikeja PMB 21005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bernadette O. Aghahon 1- 6 Oba Akinjobi Road Ikeja PMB 21005 Nigeria Self
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernadette Aghahon omodette@yahoo.com +2348038945362 1-6 Oba Akinjobi Road
City Postal code Country Position/Affiliation
Ikeja PMB 21005 Nigeria principal investiagotor
Role Name Email Phone Street address
Scientific Enquiries Joshua Akomaye microgenesis6@gmail.com 2348068219006 1-6 Oba Akinjobi Road
City Postal code Country Position/Affiliation
Ikeja PMB 21005 Nigeria Registrar
Role Name Email Phone Street address
Public Enquiries Bright Omigie bryto95@yahoo.com +2345057362241 1-6 Oba Akinjobi Road
City Postal code Country Position/Affiliation
Ikeja PMB 21005 Nigeria Assistance
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 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