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A trial to assess the retinal function of the eye when using a novel contact lens for myopia management

Evaluation of retinal ganglion cell function and ocular changes with A.R.R.E.S.T® contact lens design in emmetropic and myopic adults aged 18-25.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000823673
Enrollment
30
Registered
2023-08-01
Start date
2023-11-16
Completion date
2024-03-13
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to assess the retinal function and axial length of a prototype contact lens with a line edge pattern compared to a commercially available single vision contact lens.

Interventions

This is a prospective, randomised, contralateral clinical trial. All participants will wear one test and one control contact lens simultaneously. The eye in which each the test and control is worn will be randomly determined. All contact lenses are made from a commercially available HEMA material (55% water) and are single use. The test will be a single vision contact lens with a tinted edge pattern and the control will be single vision contact lens with no tinted edge pattern. This study will r

This is a prospective, randomised, contralateral clinical trial. All participants will wear one test and one control contact lens simultaneously. The eye in which each the test and control is worn will be randomly determined. All contact lenses are made from a commercially available HEMA material (55% water) and are single use. The test will be a single vision contact lens with a tinted edge pattern and the control will be single vision contact lens with no tinted edge pattern. This study will recruit emmetropic and myopic participants. Emmetropic participants will wear plano power contact lenses and myopic participants will wear powered contact to correct their myopia. Participants will attend one single visit. The study will comprise one visit with a total duration of approximately 80 minutes. All measurements will be performed by an optometrist. The initial measurements are performed prior to contact lens insertion, and comprise the photopic negative response (PhNR), pattern electroretinogram (PERG), and axial length. Contact lenses will be inserted after these measurements are taken. Participants will wear contact lenses and watch a greyscale television at 4 m in a room with an illumination of 700 lux for 10 minutes, after which the PhNR will be measured while wearing contact lenses. Participants will continue wearing contact lenses and watch a greyscale television at 4 m in a room with an illumination of 700 lux for a further 40 minutes, after which the PhNR and PERG will then be measured while wearing contact lenses. Adherence to watching the greyscale television will be monitored by research staff. Contact lenses will be removed, and the axial length will be measured.

Sponsors

nthalmic Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Be aged 18-25 (inclusive) male or female. Willing to comply with the clinical trial as directed by the Investigator. Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses. *Have a spherical equivalent refraction of <-0.75D (myopic group) OR between +/-0.50D (non-myopic group)

Exclusion criteria

Refractive error (myopia, hyperopia or astigmatism) greater than 3D Difference of refractive error between the eye greater than 1D Any history of significant eye injury or surgery Any major systemic disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026