A trial to assess the visual performance of novel myopia management spectacle films in short-sighted young adults
- Conditions
- MyopiaEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12624000198527
- Lead Sponsor
- nthalmic Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
•Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
•Be 18 to 45 years old, 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 wearing spectacle lenses.
•Currently wearing or have the need to wear single-vision spectacles to correct myopia.
•Meet the following criteria based on subjective refraction at Baseline:
oSpherical equivalent less than or equal to -0.50 D
oSphere component greater than or equal to -6.00 DS and less than or equal to 0 DS.
oAstigmatic component greater than or equal to -2.00 DC and less than or equal to 0 DC.
oAchieve at least 0.10 logMAR in each eye at 6 m and binocularly at 40 cm while wearing subjective distance refraction.
• Any pre-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would cause vision fluctuations.
• Any systemic disease that adversely affects ocular health e.g., diabetes, Graves’ disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
• Eye surgery within 12 weeks immediately prior to enrolment for this trial.
• Previous corneal refractive surgery.
• Known allergy or intolerance to ingredients in spectacle frames.
• Currently enrolled in another ocular clinical trial.
• Pregnancy at time of enrolment (verbal report sufficient)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in subjective visual performance ratings between the control spectacles and the test spectacle. Participants will be asked to rate their vision with each spectacle lens on a non-validated 1-10 numeric rating scale.[ Visit 3 (primary endpoint) - approximately 4 weeks post-enrolment<br>Visit 4 (primary endpoint) - approximately 6 weeks post-enrolment<br>Visit 5 (primary endpoint) - approximately 8 weeks post-enrolment]
- Secondary Outcome Measures
Name Time Method