None listed
Conditions
Brief summary
Myopia, also known as short-sightedness, is a condition of the eye that is said to affect nearly a quarter of the world population. Whilst spectacles and contact lenses compensate for the myopia and allow the eye to see clearly, they do not control the increase in eye growth that is responsible for myopia. As a result, one is required to change their spectacles or contact lenses on a regular basis to be able to see clearly. Furthermore, the more the short-sightedness progresses, the greater the risk of complications such as retinal detachment, glaucoma and myopic macular degeneration. Recent research has shown that experimental contact lenses have the potential to slow the progression of myopia by 25 to 40% on average in a group of Chinese children. These lenses have a unique design profile that is intended to discourage the eye from further growth that leads to more myopia. This study aims to find out whether we can slow down the progression of short-sightedness in Australian children when experimental contact lenses are worn compared to standard commercially-available single vision contact lenses (1-Day Acuvue Moist, Johnson & Johnson Vision Care). To achieve this, the experimental contact lens will be worn in one eye and the standard single vision lens in the other eye over a period of 1 year. The lenses will be swapped between the eyes after 6 months.
Interventions
Participants will wear a test lens in one eye and a single vision contact lens in the other eye over 12 months (two stages of 6 month duration). Lens types will be swapped between eyes after 6 months from the first stage to the second stage. There is no wash out period between stages. Contact lenses will be used on a daily wear, daily disposable wearing schedule with lens wear for all waking periods and all days of the week (minimum 8 hours/day, 6 days/week). Instructions will be provided by reg
Participants will wear a test lens in one eye and a single vision contact lens in the other eye over 12 months (two stages of 6 month duration). Lens types will be swapped between eyes after 6 months from the first stage to the second stage. There is no wash out period between stages. Contact lenses will be used on a daily wear, daily disposable wearing schedule with lens wear for all waking periods and all days of the week (minimum 8 hours/day, 6 days/week). Instructions will be provided by registered optometrists. Test lenses are prototype contact lenses (novel optical designs) manufactured in etafilcon A or methafilcon A. The two lens materials are due to resource availability. Ideally, participants will use only one material for the duration of the study so long as stock is sufficient. To monitor compliance, participants or their parent/guardian will complete a questionnaire each day noting how many hours the lenses were worn, or if not worn, why they were not worn.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Aged between 6 years to 17 years (6 years and 17 years inclusive); Spherical equivalent -0.75 D to -3.50 D with cylinder no more than -1.00 D; anisometropia of less than or equal to 0.75D Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent or have a parent / guardian who is able to give informed consent on the participant’s behalf. Be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; Have ocular health findings considered to be “normal” and which would not prevent the subject from safely wearing contact lenses; Have vision correctable to at least 6/9.5 or better in each eye with study contact lenses.
Exclusion criteria
Participants enrolled in the trial must NOT have: pre-existing ocular irritation that would preclude contact lens fitting; any systemic or ocular condition or ocular injury that may preclude safe wearing of contact lenses; undergone corneal refractive surgery; Keratoconus a known allergy to, or a history of intolerance to cyclopentolate or topical anaesthetics; at baseline, astigmatism more than 1.00 D in either eye; had strabismus and/or current ongoing amblyopia; any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity; current orthoptic treatment or vision training; eye injury or surgery within 12 weeks immediately prior to enrolment for this trial; undergone atropine treatment for myopia control; worn bifocal or progressive addition spectacles or anti-myopia contact lenses previously; worn orthokeratology lenses previously; require anticholinergic medication for gastrointestinal or other conditions; at baseline, be anisometropic by more than 0.75D;
Outcome results
None listed