None listed
Conditions
Brief summary
The purpose of this trial is to compare the visual performance of various spectacle films (test) against films without optical features (control). Visual performance will be assessed with vision testing and questionnaires completed by the participant. The films are made of polycarbonate material and have been designed to provide optical features for the use by people with short-sightedness. It is hypothesized the visual performance of test films will be no different to the control film.
Interventions
This trial will be a prospective, bilateral, randomised, single-masked (participant), cross-over clinical trial. Participants will wear up to 11 different test spectacles with lens films (at optometrist’s discretion) and control spectacles. All the test films are configured with peripheral optical features to purposefully create peripheral retinal defocus, which has been shown to reduce the rate of myopia progression when applied to both spectacles and contact lenses. The location of the optical
This trial will be a prospective, bilateral, randomised, single-masked (participant), cross-over clinical trial. Participants will wear up to 11 different test spectacles with lens films (at optometrist’s discretion) and control spectacles. All the test films are configured with peripheral optical features to purposefully create peripheral retinal defocus, which has been shown to reduce the rate of myopia progression when applied to both spectacles and contact lenses. The location of the optical features within the films are configured differently between the 11 test designs, both in terms of the number of optical features contained in each film and in the orientation and placement of each optical feature. One example of the test design is D1O2, where D1 denotes the design number of the optical features and O2 denotes the orientation and placement of the optical features. The final pair of test films within the spectacles is then known as N1 through to N11. The lens films will be specifically designed for this trial by nthalmic. Lens films are made of polycarbonate material and are visually clear. All spectacles will be worn for up to 5 days for a minimum of 6 hours/day, there is no limit to the maximum hours spectacles are worn. Participants will choose a frame design from a designated pool of standard test frames. 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 new frames and lenses for each test, but each participant will use the same model and size frame with the same prescription for each lens film. Each participant will attend for up to 5 visits, depending on the number of test spectacles with lens films that are worn. Assuming a participant wears 11 test spectacles with lens films, they will attend for 5 visits comprising visit 1 (baseline), visit 2 (1st set of spectacle lens dispensed), visit 3 (1st spectacle lens collection and 2nd set of spectacle lens dispensed), visit 4 (2nd spectacle lens collection and 3rd set of spectacle lens dispensed) and visit 5 (3rd spectacle lens collection). Up to four spectacles will be dispensed at visits 2, 3 and 4. There will be no spectacles given at baseline or visit 5 as this is the final spectacle collection visit. Visit 1, 3 and 4 will be approximately 60min duration and visit 2 and visit 5 will be approximately 30min duration. The timing between visits will be approximately 2-3 weeks apart. Visit 1 will comprise standard subjective refraction and measurement of visual acuity obtained with refraction. A standard logMAR visual acuity chart will be used. Spectacle lens dispense visits will include visual acuity measurements using standard logMAR visual acuity charts. Spectacle lenses will be dispensed. Spectacle collection visits will involve only the collection of used spectacles. All assessments will be carried out by an optometrist. Participants will be instructed to wear allocated spectacle lenses as per the schedule and return all spectacles. There is no 'wash-out' period between treatments. Compliance will be assessed by verbal questioning of participants. Questionnaires will be administered to participants after each spectacle lens wear.
Sponsors
nthalmic Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 40 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 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.
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 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.
Outcome results
None listed