RecruitingPhase 4ACTRN12624000383561

Can eye drops safely replace reading glasses in older adults?

Investigating the effects of long-term pilocarpine use for presbyopia treatment on posterior ocular structures

Sponsor

The University of Auckland

Enrollment

24 participants

Start Date

Aug 25, 2025

Study Type

Interventional

Conditions

Retinal ischaemia Presbyopia

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.

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

Almost everyone develops presbyopia — the gradual loss of near vision — in middle age, making reading glasses a near-universal experience after your 40s. A new prescription eye drop called Vuity (pilocarpine 1.25%) has emerged as a non-surgical treatment that temporarily improves close-up vision. However, its long-term safety on the back of the eye has not been adequately studied. This Phase 4 study at the University of Auckland will track participants using Vuity eye drops over an extended period to check whether the drops affect the retina (the light-sensing layer at the back of the eye) and the choroid (the blood vessel layer beneath it). Researchers will measure layer thickness, blood flow, and electrical activity of the retina. You may be eligible if you are aged 40–55, wear glasses or contact lenses only for reading (not for distance), and are otherwise in good eye health. You would not be eligible if you have certain eye conditions, take medications that interact with the drops, are pregnant or planning to become pregnant, or have significant astigmatism.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.