Can eye drops safely replace reading glasses in older adults?

Phase 4

• Conditions: Presbyopia; Eye - Diseases / disorders of the eye; Retinal ischaemia

• Registration Number: ACTRN12624000383561
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-04-02
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 21

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

- Ametropia, defined as over 0.50 Dioptres of myopic or hyperopic mean sphere refractive error
- History of ocular disease, injury, or surgery that affects or has the potential to affect the participant’s vision over the study duration
- Any history of ocular or systemic conditions that are contraindications for receiving pilocarpine eye drops as a medical therapy that would put participants' safety at risk.
- A personal or family history of epilepsy or seizures, neurological disorders/ disease, or serious head injury and/or skull fracture, as these may affect performance in MRI procedures involving viewing flickering visual patterns (e.g. epilepsy) and/or lying still for an extended period of time (e.g. claustrophobia)
- Having metal implants (e.g. a cardiac pacemaker) or other contraindications that would put the safety of the participant at risk when undergoing an MRI scan
- Pregnant or breastfeeding women, as safety of pilocarpine eye drops has not been established for use in pregnancy and lactation. For this reason, participants who become pregnant during the study will also not be able to continue participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in choroidal thickness. Measurements of subfoveal choroidal thickness[Optical coherence tomography (OCT) scan Baseline, end of first treatment block (3 months), end of 2-week washout (3.5 months), then end of second treatment block (6.5 months)];Change in global flash multifocal electroretinogram (gmfERG) waveform in central retinal location. The gmfERG waveform can be characterised by the signal amplitudes and latencies of the direct and induced retinal responses.[Global flash multifocal electroretinography (gmfERG) Baseline, end of first treatment block (3 months), end of 2-week washout (3.5 months), then end of second treatment block (6.5 months)];Change in chorioretinal blood perfusion.[3-dimensional pseudo-continuous arterial spin labelling (pCASL) magnetic resonance imaging (MRI) Baseline, end of first treatment block (3 months), end of 2-week washout (3.5 months), then end of second treatment block (6.5 months)]