None listed
Conditions
Brief summary
The purpose of this trial is to compare the visual performance of various novel myopia management spectacles to a commercial control spectacle in myopic young adults. Visual performance will be assessed with vision testing and questionnaires. It is hypothesized the visual performance of test spectacles will be no different to control spectacles.
Interventions
This will be a prospective, bilateral, randomised, single-masked (participant), cross-over clinical trial. Participants will wear up to 9 different test spectacles and one control spectacle (i.e., 10 study spectacles in total). All test spectacles are configured with peripheral optical features comprising lights words and axicons in different orientations comprising spoke, radial, and spiral patterns (or combinations of these patterns), and different configurations of axicons or light swords in
This will be a prospective, bilateral, randomised, single-masked (participant), cross-over clinical trial. Participants will wear up to 9 different test spectacles and one control spectacle (i.e., 10 study spectacles in total). All test spectacles are configured with peripheral optical features comprising lights words and axicons in different orientations comprising spoke, radial, and spiral patterns (or combinations of these patterns), and different configurations of axicons or light swords in the mid-periphery to the periphery of the spectacle lens, that are hypothesized to reduce the rate of myopia progression. The orientation and configurations of the optical features are configured differently between the 9 test designs and will be known as P1 through to P9. Test spectacle lenses are made of polycarbonate material and are to be worn for up to 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 for up to 5 visits, depending on the number of study spectacles that are worn. Assuming a participant wears 10 study spectacles (9 test, one control), 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 study spectacles will be dispensed at visits 2, 3 and 4. There will be no study spectacles given at baseline (visit 1) as this is the first visit, nor at 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 dispensing visits (visits 2-4) will include visual acuity measurements using standard logMAR visual acuity charts and heterophoria measurements using standard phoria cards. Spectacle collection visits will involve only the collection of used study spectacles. All assessments will be carried out by an optometrist. Participants will be instructed to wear allocated study spectacles for up to 5 days, and a minimum of 6 hours per day. 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 study spectacle has been worn for 3 days.
Sponsors
Shanghai iSparX Medical 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 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 at least 18 years old and less than 45 years (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 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: Spherical equivalent less than or equal to -0.50 D Spherical component between -6.00 DS and 0 DS (inclusive). Astigmatic component between -2.00 DC and 0 DC (inclusive). Achieves 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) 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