None listed
Conditions
Brief summary
Cyclopentolate 1% is the recommended drug of choice to induce cycloplegia during paediatric eye examinations. Cycloplegia forms part of the standard of care in the diagnosis and management of refractive error, strabismus, and ocular disease in children. Given this procedure is required for best practice, it is concerning that instillation of cyclopentolate eyedrops can cause significant distress to children during eye examinations due to sting on instillation and discomfort during the administration process. Variables that contribute to sting and discomfort include the low pH of commercially available formulations of cyclopentolate, the size of the eye drop, and the mode of administration. This project aims to assess the effects that these variables have on sting and distress by comparing the sting and discomfort of the two commercially available, TGA approved formulations, Cyclogyl (Alcon) and Cyclopentolate Minims (Bausch and Lomb) (with differing pH levels) administered via alternative delivery methods (micro-drop to reduced drop size and spray to alter administration mode) to study participants. The tolerability and efficacy of a final alternative delivery method (micro-drop or spray) and with which cyclopentolate product (Minims or Cyclogyl) will be determined in adults through Study 1, before being administered to children in Study 2 (to be registered at a later date once data analysis is completed and 'final alternative delivery method' determined from Study 1). Even though cyclopentolate eye drops are the drug of choice for cycloplegia in children, recruiting adults for Study 1 will help to alleviate unnecessary burden of repeated visits and procedural anxiety on children.
Interventions
What is the drug/intervention: Cyclopentolate Hydrochloride 1% eye drops - micro drop and spray administration of TGA approved products
Dose: 1-2 drops (or spray doses) per eye
Duration of treatment: Study 1 (adults) 6x visits (total; 4x interventional, 2x comparator)
Mode of delivery: Topical (eye)
Adherence: Nil required, administered during study visit only
Who delivers it and their relevant expertise: Lead Researcher delivers the eye drop in micro-drop or spray form, lead researcher is a
What is the drug/intervention: Cyclopentolate Hydrochloride 1% eye drops - micro drop and spray administration of TGA approved products Dose: 1-2 drops (or spray doses) per eye Duration of treatment: Study 1 (adults) 6x visits (total; 4x interventional, 2x comparator) Mode of delivery: Topical (eye) Adherence: Nil required, administered during study visit only Who delivers it and their relevant expertise: Lead Researcher delivers the eye drop in micro-drop or spray form, lead researcher is a therapeutically qualified, AHPRA registered optometrist. How is it delivered: Face to face, topical administration within study visits How often and for how long: Study 1 total of 6x 1.5-2 hour study visits (4x interventional, 2x comparator) spaced at least 2 days apart, Where is it delivered: Clinic/laboratory setting Description of study conditions, each administered on a separate visit in randomised order: 1. Standard drop delivery (~30µl) of commercially available Cyclopentolate 1% Minims (pH ~3.6, Bausch & Lomb) (comparator) 2. Standard drop delivery (~40µl) of commercially available Cyclogyl 1% (pH ~4.5, Alcon) (comparator) 3. Micro-drop delivery (~10µl) of commercially available Cyclopentolate 1% Minims (pH ~3.6, Bausch and Lomb) (interventional) 4. Micro-drop delivery (~10µl) of commercially available Cyclogyl 1% (pH ~4.5, Alcon) (interventional) 5. Spray delivery (120-160µl) of commercially available Cyclopentolate 1% Minims (pH ~3.6, Bausch and Lomb) (interventional) 6. Spray delivery (120-160µl) of commercially available Cyclogyl 1% (pH ~4.5, Alcon) (interventional) Description of administration protocols: Standard drop delivery: Standard eye drop delivery to the inferior fornix of open eyes, head slightly reclined and participant looking toward the ceiling Micro-drop delivery: Nanodropper device; No change to original drug prescribed dosage regimen or protocol. The device simply reduces the volume of the drop administered. The Nanodropper is attached to the existing eye dropper bottle and eye drops are instilled as per standard cyclopentolate administration to the inferior fornix of open eyes, head slightly reclined and participant looking toward the ceiling. Spray delivery: Fine Mist Fingertip Sprayer (S703WH) and 6ml Amber Glass Bottle; The participant is to close their eyes (gently where possible) and maintain an upright position. Holding the spray bottle upright and directed slightly downwards towards the superior lash line, administer one to two metered sprays to each of the closed eyes in quick succession from approximately 3-5cm away to induce pupil dilation. The participant is then asked to open eyes and blink for 5-10 seconds to allow the drug to enter the tear film. The participant is advised to not touch/rub their eye directly, however any excess drug on the surface of the skin can be blotted away with a tissue.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
Study 1: Healthy adults between 18-39 years of age with a range of refractive error (+10 to -10 dioptres (spherical equivalent)) and iris colour, and age normal amplitude of accommodation.
Exclusion criteria
Any contraindications to receiving cyclopentolate hydrochloride including: History of - cardiovascular disorders, Down’s syndrome or any organic brain syndromes (including congenital or neurodevelopmental abnormalities), diabetes, severe cognitive impairment or severe medical conditions making it difficult to understand and respond appropriately to questions, currently pregnant or breastfeeding, glaucoma or intraocular pressure greater than 21mmHg in each eye, narrow anterior chamber angles, ocular disease (excluding refractive error and/or strabismus), amblyopia (BCVA worse than 6/9.5 and/or worse than N5 vision at near in either eye), astigmatism greater than 1.5D, ocular trauma or surgery, pupil abnormalities, contact lens wear or dry eye syndrome, NIKBUT-average time of 7s or lower, known allergy or hypersensitivity to cyclopentolate and/or atropine, current prescribed eye drop use of any kind. In the opinion of the lead researcher, be unwilling or unable to comply with the trial protocol.
Outcome results
None listed