A trial to assess the visual performance of spectacle films in short-sighted young adults
- Conditions
- MyopiaEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12621001264875
- Lead Sponsor
- nthalmic Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 44
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
Be greater than or equal to 18 years old but less than or equal to 40 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.
Myopic spherical equivalent correction less than or equal to -0.75 D
A cylindrical correction greater than or equal to -2.00DC
Have best-corrected visual acuity at least 6/7.5.
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 clinical trial.
Pregnancy at time of enrolment - verbal report sufficient
The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective visual performance ratings between test and control spectacle films. Participants will be asked to rate their vision with each spectacle lenses on a non-validated 1-10 numeric rating scale[Following visit 2 (approximately 2 weeks post-enrolment): at 3 days, 8 days, 13 days and 18 days post visit 2 - primary timepoint<br>Following visit 3 (approximately 5 weeks post-enrolment): at 3 days, 8 days, 13 days and 18 days post visit 3 - primary timepoint<br>Following visit 4 (approximately 8 weeks post-enrolment): at 3 days, 8 days, 13 days and 18 days post visit 4 - primary timepoint]
- Secondary Outcome Measures
Name Time Method Visual acuity measures between test and control spectacle films. Visual acuity will be measured with standard logMAR chart at 6m[Visit 2: (approximately 2 weeks post-enrolment)<br>Visit 3: (approximately 5 weeks post-enrolment) <br>Visit 4: (approximately 8 weeks post-enrolment)];Binocular vision between test and control spectacle films. <br>Binocular vision assessments comprise the measurement of distance and near phoria and will be measured using the modified Thorington technique. [Visit 2: (approximately 2 weeks post-enrolment)<br>Visit 3: (approximately 5 weeks post-enrolment) <br>Visit 4: (approximately 8 weeks post-enrolment)];Contrast sensitivity measures between test and control spectacle films. Contrast sensitivity will be measured using a standard Pelli-Robson contrast sensitivity letter chart.[Visit 2: (approximately 2 weeks post-enrolment)<br>Visit 3: (approximately 5 weeks post-enrolment) <br>Visit 4: (approximately 8 weeks post-enrolment)]