None listed
Conditions
Brief summary
The purpose of this trial is to compare the visual performance of spectacle lenses with films compared to commercial control spectacles in young myopic adults. Visual performance will be assessed with vision testing and questionnaires. It is hypothesized the visual performance of the test spectacle with film will be no different to control spectacles.
Interventions
The phone number for the principal investigator and contact person for public queries is the same. This is because both people are employees of nthalmic Pty Ltd, and this is nthalmic's only professional phone number. All queries will be fielded by an nthalmic employee, and then the query will be directed to the appropriate person.
This trial will be a prospective, bilateral, randomised, crossover clinical trial. Participants will wear one test single-vision spectacle with lens film and two con
The phone number for the principal investigator and contact person for public queries is the same. This is because both people are employees of nthalmic Pty Ltd, and this is nthalmic's only professional phone number. All queries will be fielded by an nthalmic employee, and then the query will be directed to the appropriate person. This trial will be a prospective, bilateral, randomised, crossover clinical trial. Participants will wear one test single-vision spectacle with lens film and two control spectacles. The test film is made of polycarbonate and contains an edge pattern. All spectacles will be worn for at least 5 days for a minimum of 6 hours/day. There is no limit to the maximum number of hours spectacles are worn. Participants will choose a spectacle frame and all fittings will be confirmed by an optometrist. The distance power of the spectacle lenses will be power-matched to the participant's myopic refractive error. Participants will be dispensed a new frame for each study spectacle, but an identical frame (same model, size, and colour), the same prescription, and the same optical centration will be used for each study spectacle. Each participant will attend 5 visits comprising of Visit 1 (baseline), Visit 2 (Spectacle Dispensing visit 1), Visit 3 (Spectacle Assessment visit 1 + Spectacle Dispensing visit 2), Visit 4 (Spectacle Assessment visit 2 + Spectacle Dispensing visit 3) and Visit 5 (Spectacle Assessment visit 3). All 3 spectacles will be dispensed at the Dispensing visits, with no spectacles given at baseline (Visit 1) as this is the first visit, nor at Visit 5 as this is the final visit. Visit 1, 3 and 4 will be approximately 60min duration and Visit 2 and 5 will be approximately 30min duration. The timing between visits will be approximately 2 weeks apart. Visit 1 (Baseline) will comprise standard subjective refraction, measurement of visual acuity obtained with refraction and axial length measurements. A standard logarithm of the minimum angle of resolution (logMAR) visual acuity chart will be used. Visit 2 (Spectacle Dispensing 1) will include visual acuity measurements using standard logMAR visual acuity charts. Visit 3 (Spectacle Assessment 1/Dispense 2) will include visual acuity measurements using standard logMAR visual acuity charts and heterophoria measurements using standard phoria cards. Axial length will also be measured. Visit 4 (Spectacle Assessment 2/Dispense 3) will include visual acuity measurements using standard logMAR visual acuity charts and heterophoria measurements using standard phoria cards. Axial length will also be measured. Visit 5 (Spectacle Assessment 3) will include visual acuity measurements using standard logMAR visual acuity charts and heterophoria measurements using standard phoria cards. Axial length will also be measured. All assessments will be carried out by an optometrist. There is no 'wash-out' period between treatments. Compliance will be assessed by verbal questioning of participants. Questionnaires will be administered to participants at each Spectacle Assessment visit.
Sponsors
nthalmic Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
• 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: o Spherical equivalent less than or equal to -0.50 D o Sphere component greater than or equal to -6.00 DS and less than or equal to 0 DS. o Astigmatic component greater than or equal to -2.00 DC and less than or equal to 0 DC. o Achieve at least 0.10 logMAR in each eye at 6 m and binocularly at 40 cm while wearing subjective distance refraction.
Exclusion criteria
• 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)
Outcome results
None listed