None listed
Conditions
Brief summary
Everyone who reaches middle age will eventually need reading glasses due to an age-related eye condition known as presbyopia. Recently, Vuity eye drops (pilocarpine 1.25%) have emerged as an effective treatment for the blurry near vision that comes with presbyopia. However, the safety concerns that accompany this treatment have not yet been adequately addressed. This research aims to determine whether long-term use of Vuity eye drops affects the health of the eye –particularly the retina and choroid tissue layers at the back of the eye– to confirm its safety as a treatment for presbyopia in New Zealand. We will assess this by monitoring the thickness of the choroid, blood flow within the chorioretinal layers, and electrical activity of the retina.
Interventions
This study is a prospective, two-way cross-over clinical trial consisting of two 3-month treatment blocks. Participants will be randomly allocated to either receive the intervention or control in the first treatment block.
The study intervention is Pilocarpine hydrochloride 12.5 mg/mL (1.25%) eye drops. Participants allocated to receive the intervention in the first treatment block will be given these eye drops to administer one drop twice daily in both eyes, in place of wearing their reading g
This study is a prospective, two-way cross-over clinical trial consisting of two 3-month treatment blocks. Participants will be randomly allocated to either receive the intervention or control in the first treatment block. The study intervention is Pilocarpine hydrochloride 12.5 mg/mL (1.25%) eye drops. Participants allocated to receive the intervention in the first treatment block will be given these eye drops to administer one drop twice daily in both eyes, in place of wearing their reading glasses or contact lenses, for a period of 3 months (i.e. the duration of a treatment block). Participants allocated to receive the control in the first treatment block will not receive the intervention, and wear their reading glasses or contact lenses, for a period of 3 months (i.e. the duration of a treatment block). After the first 3-month treatment block, there will be a 2-week 'wash out' period during which no participants will administer the eye drop intervention and all participants will wear their reading glasses or contact lenses (control). After this 'wash out' period, participants will cross-over to the opposite treatment for the next 3-month treatment block (i.e. those who received the intervention in the first treatment block will wear their reading glasses or contact lenses, while those who received the control will be given the intervention eye drops to administer one drop up to twice daily in both eyes, in place of wearing their reading glasses or contact lenses). Every week during each 3-month treatment block, participants will be asked to estimate their adherence to their allocated treatment over the previous 7-day period. At select time points, participants will also be asked to complete a questionnaire about their near vision function, spectacle independence, and satisfaction with the allocated treatment. At the end of the trial, participants will be asked which of the treatments they preferred using to manage their presbyopia.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adults who only wear optical correction (glasses and/or contact lenses) for presbyopia correction, and are willing and able to provide written informed consent for study participation.
Exclusion criteria
Medical conditions - Uncontrolled systemic disease or clinically significant disease state in any body system that, in the opinion of the investigator, could have affected the safety of the individual or interpretation of endpoint measures - History of ocular pathology or intraocular surgery that, in the opinion of the investigator, could have affected the safety of the individual or interpretation of endpoint measures Contraindications for Vuity eye drops - Known allergy or sensitivity to pilocarpine, other components in Vuity eye drops, or other cholinergic agonist medications - Narrow iridocorneal angles that are at risk of angle-closure and physiological anisocoria of >1 mm between pupils, as these conditions could affect the safety of the individual or interpretation of endpoint measures Prior/Concomitant therapy - Use of any topical prescription or over-the-counter ophthalmic medications that, in the opinion of the investigator, could have a substantial effect on visual function and affect interpretation of endpoint measures - Use of systemic medications with potential ocular side effects, including topiramate, hydroxychloroquine, ethambutol, phosphodiesterase 5 inhibitors (sildenafil, vardenafil, tadalafil), or tamoxifen, that could have a substantial effect on visual function and affect interpretation of endpoint measures - Use of systemic or intranasal anticholinergics and alpha-adrenergic receptor agonists with potential pupillary or accommodative effects, including oxymetazoline, tetrahydrozoline, phenylephrine, naphazoline, atropine, pilocarpine, beta-blockers, or antihistamines, that could have a substantial effect on visual function and affect interpretation of endpoint measures - Use of systemic maprotiline, tricyclic antidepressants, or monoamine oxidase inhibitors, that could have a substantial effect on visual function and affect interpretation of endpoint measures Diagnostic assessments - Astigmatic refractive error based on non-cycloplegic subjective refraction, defined as a magnitude of astigmatism of 1.00 Dioptres or higher. - Monocular unaided distance visual acuities poorer than 0.20 logMAR (Snellen 6/9.5) in both eyes, as this may be indicative of significant ametropia that may affect the interpretation of endpoint measures - Monocular best-corrected distance visual acuities poorer than 0.00 logMAR (Snellen 6/6) in both eyes, as this may be indicative of an underlying ocular condition or abnormality that may affect the safety of the individual or interpretation of endpoint measures Other - Females who are not pregnant or breastfeeding, and are not considering becoming pregnant or donating eggs during the study or for ~30 days after the last dose of study intervention, as safety of Vuity eye drops has not been established for use in pregnancy and lactation.
Outcome results
None listed