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

Not Applicable

Completed

• Conditions: Myopia; Eye - Normal eye development and function

• Registration Number: ACTRN12623000823673
• Lead Sponsor: nthalmic Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study Completion: 2024-03-13
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in PhNR between eyes. PhNR will be measured using a standard electro-retinographer. [ Time 0 (prior to contact lens insertion)<br>Approximately 10 minutes after contact lens insertion (while wearing contact lenses). <br>Approximately 50 minutes after contact lens insertion (while wearing contact lenses). ]

Secondary Outcome Measures

Name	Time	Method
Difference in PERG between eyes. PERG will be measured using a a standard electro-retinographer. [ Time 0 (prior to contact lens insertion)<br>Approximately 50 minutes after contact lens insertion (while wearing contact lenses). ];Axial length<br>Difference in axial length between eyes. Axial length will be measured using a standard ocular biometer.[ Time 0 (prior to contact lens insertion)<br>Approximately 50 minutes after contact lens insertion (contact lenses removed before measurement). ]