None listed
Conditions
Brief summary
Myopia (also known as near or short sightedness) is a condition of the eye where objects viewed in the distance appears blurred. Conventional methods of correcting this optical condition include spectacles and contact lenses. The rate of progression of myopia tends to be more rapid in the younger age and high degrees of myopia can lead to complications such as retinal degeneration and detachments, choroidal neovascular membranes and an increased risk of primary open angle glaucoma. Numerous studies have investigated different contact lens optical designs to correct and potentially treat myopia. One theory in the attempt to reduce myopia progression is to target the stimulus on the peripheral retina. Previous studies have shown that the peripheral retinal stimulus plays a role in myopia progression. It is now known that peripheral hyperopia, where the stimulus or focus falls behind the retina, can be a trigger for myopia progression. Myopic eyes tend to have peripheral hyperopia and unfortunately the design of conventional spectacles and contact lenses used to correct myopia, actually exacerbates this. Thus, in an attempt to minimise myopia progression, the optical design of contact lens should bring the focus from behind the retinal periphery to either on or in front of the retinal periphery. This concept has been tested in contact lenses previously and progression of myopia was found to be 34% less than when wearing spectacles only. Newer optical designs with this concept are required to be tested to enhance the myopic progression effect, however, as the lens designs are novel, myopic participants are required to test the lenses and ensure both vision and subjective acceptance of the lens prior to longer term assessments on the efficacy of these lenses. Previously conducted clinical studies assessed numerous prototype lenses after short-term (1.5 and 6 hours) lens wear compared to commercially available equivalent contact lenses in adults. The best performing prototype lenses from the short-term trial have been selected for further testing in the current study against the best performing commercial contact lenses for use in children and young adults.
Interventions
Prospective, participant-masked, clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Up to 6 contact lens designs will be assessed against commercial control lens. The 6 lens designs are the top performing designs based on the results of a non-dispensing pilot study, which assesses the short-term visual performance in adults. The designs differ by power variations across the lens surface. It is voluntary for all the participants to complete
Prospective, participant-masked, clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Up to 6 contact lens designs will be assessed against commercial control lens. The 6 lens designs are the top performing designs based on the results of a non-dispensing pilot study, which assesses the short-term visual performance in adults. The designs differ by power variations across the lens surface. It is voluntary for all the participants to complete all six stages and no 'washout' is required between each stage. Participants will wear the lenses on a daily wear, daily disposable basis for up to 7 days before crossing over to the next lens design. Questionnaires will need to be completed on day 2, 4 and 6.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
7 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
*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 between 7 and 18 years old (inclusive), male or female. *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 participant from safely wearing contact lenses. *Correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
Exclusion criteria
*Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses. *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. *Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial. *Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used. *Eye surgery within 12 weeks immediately prior to enrolment for this trial. *Previous corneal refractive or strabismus surgery. *Any binocular vision problems which may be exacerbated with the use of the study products or prevent adequate use of the device such as amblyopia, strabismus, excessive phoria and accommodative or convergence difficulties. *Contraindications to contact lens wear. *Known allergy or intolerance to ingredients in any of the clinical trial products
Outcome results
None listed