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Trial registered on ANZCTR


Registration number
ACTRN12624000383561p
Ethics application status
Not yet submitted
Date submitted
26/02/2024
Date registered
2/04/2024
Date last updated
2/04/2024
Date data sharing statement initially provided
2/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can eye drops safely replace reading glasses in older adults?
Scientific title
Investigating the effects of long-term pilocarpine use for presbyopia treatment on posterior ocular structures
Secondary ID [1] 311574 0
Nil known
Universal Trial Number (UTN)
U1111-1304-5173
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 332950 0
Retinal ischaemia 332951 0
Condition category
Condition code
Eye 329663 329663 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 by permuted block randomisation, stratified by gender.

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 up to 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 will be asked to record their daily eye drop useage in a study diary, and will be subject to monthly email check-ins.

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 treatment). 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 continue wearing 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).
Intervention code [1] 328027 0
Treatment: Drugs
Intervention code [2] 328028 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will serve as their own control. The standard treatment for presbyopia is via optical correction (with glasses and/or contact lenses), outcome measures obtained under standard optical correction (control) will be compared to under instillation of eye drops (intervention) for presbyopia treatment.

When participants are allocated to receive the control treatment, they will be instructed to wear their standard reading glasses or contact lenses for a period of 3-months (i.e. the duration of a treatment block).
Control group
Active

Outcomes
Primary outcome [1] 337462 0
Change in choroidal thickness. Measurements of subfoveal choroidal thickness
Timepoint [1] 337462 0
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)
Primary outcome [2] 337463 0
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.
Timepoint [2] 337463 0
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)
Primary outcome [3] 337465 0
Change in chorioretinal blood perfusion.
Timepoint [3] 337465 0
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)
Secondary outcome [1] 431983 0
Change in chorioretinal vascular and perfusion density. Vascular density can be divided into several components: superficial capillary plexus (SCPs), deep capillary plexus (DCP), and choriocapillaris (CC), but will be assessed together as a composite outcome
Timepoint [1] 431983 0
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)
Secondary outcome [2] 432065 0
Change in patient-reported outcomes on spectacle independence
Timepoint [2] 432065 0
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)
Secondary outcome [3] 433344 0
Change in choroidal thickness. Measurements of peripheral choroidal thickness
Timepoint [3] 433344 0
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)
Secondary outcome [4] 433345 0
Change in global flash multifocal electroretinogram (gmfERG) waveform in peripheral retinal location. The gmfERG waveform can be characterised by the signal amplitudes and latencies of the direct and induced retinal responses.
Timepoint [4] 433345 0
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)

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
GraphPad Prism (GraphPad Software, San Diego, CA) and/or SPSS Statistics (IBM, Armonk, NY) will be used for conducting statistical analyses. All statistical tests will be two-tailed and at 5% significance level throughout the analyses. Summaries of continuous variables which are normally distributed will be presented as means and standard deviations or medians and inter-quartiles for skewed data, while categorical variables will be presented as frequencies and percentages. Paired t-test will be used to test for differences in endpoint measures between presbyopia correction with optical correction vs. pilocarpine eye drops. The assumption of normality of data will be assessed by visual inspection of Normal Q-Q plots and/or Shapiro-Wilk test of normality. Upon violation of the assumption of normality, a nonparametric Wilcoxon signed-rank test will be conducted instead of a paired t-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment outside Australia
Country [1] 26178 0
New Zealand
State/province [1] 26178 0
Auckland

Funding & Sponsors
Funding source category [1] 315873 0
Charities/Societies/Foundations
Name [1] 315873 0
The Association for Research in Vision and Ophthalmology
Country [1] 315873 0
United States of America
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318013 0
None
Name [1] 318013 0
Address [1] 318013 0
Country [1] 318013 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314721 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314721 0
Ethics committee country [1] 314721 0
New Zealand
Date submitted for ethics approval [1] 314721 0
11/04/2024
Approval date [1] 314721 0
Ethics approval number [1] 314721 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132518 0
Dr Alyssa Lie
Address 132518 0
School of Optometry and Vision Science The University of Auckland 85 Park Road, Grafton Auckland 1023
Country 132518 0
New Zealand
Phone 132518 0
+64 21 0266 4662
Fax 132518 0
Email 132518 0
a.lie@auckland.ac.nz
Contact person for public queries
Name 132519 0
Alyssa Lie
Address 132519 0
School of Optometry and Vision Science The University of Auckland 85 Park Road, Grafton Auckland 1023
Country 132519 0
New Zealand
Phone 132519 0
+64 21 0266 4662
Fax 132519 0
Email 132519 0
a.lie@auckland.ac.nz
Contact person for scientific queries
Name 132520 0
Alyssa Lie
Address 132520 0
School of Optometry and Vision Science The University of Auckland 85 Park Road, Grafton Auckland 1023
Country 132520 0
New Zealand
Phone 132520 0
+64 21 0266 4662
Fax 132520 0
Email 132520 0
a.lie@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.