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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202011892936115 Date of Registration: 02/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title INTRACAMERAL VERSUS TOPICAL MYDRIATIC AGENTS IN MANUAL SMALL INCISION CATARACT SURGERY AMONG PATIENTS IN LAGOS STATE UNIVERSITY TEACHING HOSPITAL.
Official scientific title INTRACAMERALVERSUS TOPICAL MYDRIATIC AGENTS IN MANUAL SMALL INCISION CATARACT SURGERY AMONG PATIENTS IN LAGOS STATE UNIVERSITY TEACHING HOSPITAL.
Brief summary describing the background and objectives of the trial Cataract surgery is one the most common surgeries performed in Ophthalmology in Nigeria. Effective mydriasis is pivotal to ensuring good outcomes in cataract surgery. Traditionally, mydriasis is achieved via instillation of topical agents but this is fraught with quite a number of disadvantages. Intracameral mydriasis has been well researched in phacoemulsification technique of cataract surgery and found to be effective and safe. This study aims to compare the efficacy and safety of intracameral mydriatic agents in treatment of cataract using the manual small incision technique.
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 03/01/2021
Actual trial start date 05/04/2022
Anticipated date of last follow up 31/07/2021
Actual Last follow-up date 04/02/2022
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 102
Recruitment status Completed
Publication URL https://gjcsro.com/comparison-of-pupil-dilation-in-manual-small-incision-cataract-surgery-using-topical-versus-intracameral-mydriatic-agents-a-randomised-controlled-trial/
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Topical Mydriasis 4 drops at 15 minute intervals 1hour A drop of a combination of Tropicamide 1% and Phenylephrine 5% is instilled into the eye 1 hour before surgery 51 Historical
Experimental Group Intracameral Mydriasis 0.5ml 30 seconds A combination of preservative free Lidocaine 0.5% and Epinephrine 0.001% is injected into the posterior chamber of the eye inta-operatively 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18years and above Patients with uncomplicated cataract Patients that give consent to the study Patients aged less than 18 years Pregnancy/breastfeeding women, History of uveitis, History of intake of alpha blockers, use of topical or systemic nonsteroidal anti‑inflammatory drugs/prostaglandins/miotics. Presence of corneal opacities or pupillary deformities History of surgery in same eye Hypersensitivity to any component of medicines used. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 09/11/2020 LASUTH Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 - 5, Oba Akinjobi way, GRA, Ikeja Lagos 100212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pupil diameter Before instillation of topical mydriatics for the mydriatic group and just before giving local anaesthetic block for the intracameral group.
Primary Outcome Pupil diameter One minute after entering the anterior chamber for topical group and 30 seconds after injection in the mydriatic group.
Primary Outcome Pupil diameter After nucleus delivery
Primary Outcome Pupil diameter At intraocular lens implantation
Primary Outcome Pupil diameter At the end of the surgery
Primary Outcome Visual Acuity At Day 1, Week 1 and Week 3 post-operatively
Secondary Outcome Anterior Chamber inflammatory activity At Day 1, Week 1 and Week 3 post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital 1 - 5 , Oba Akinjobi way, GRA , Ikeja Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibukunoluwa ADEOGUN 7, oke street, Akowonjo Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibukunoluwa Adeogun 7, Oke street, Akowonjo Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibukunoluwa Adeogun ibkciti@gmail.com +2347035923157 1 - 5, Oba Akinjobi way , GRA , Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries T Alakija lasuthethics@gmai.com +2348055262563 1 - 5, Oba Akinjobi way , GRA , Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Ethics Committee
Role Name Email Phone Street address
Scientific Enquiries Modupe Idris dupebal@yahoo.co.uk +2348033123069 1 - 5, Oba Akinjobi way , GRA , Ikeja
City Postal code Country Position/Affiliation
Lagos Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that will underlie the results of the study. Statistical Analysis Plan,Study Protocol 2years Access will be controlled and request will be approved by Dr Modupe Idris , HOD department of Ophthalmology, LASUTH .
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