ACTRN12623000319673
Recruiting
未知
Prospective, cross-over pilot trial to assess the short-term efficacy of novel myopia management spectacle films and contact lenses when worn by children.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- nthalmic Pty Ltd
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged between 7\-15 years inclusive
- •Have read, understood and signed informed assent
- •Parents have read, understood and signed informed consent
- •Adhere to study requirements, wear study products and maintain visit schedule
- •Have good general health and normal ocular health
- •Best\-corrected high contrast visual acuity of 6/7\.6 or better in each eye
- •If wearing spectacle study product: Spectacle refraction of:
- •\-sphere component between \-0\.50DS and \-4\.00DS inclusive and spherical equivalent less than or equal to \-0\.75D
- •\-Astigmatic correction between 0DC and \-1\.50DC inclusive
- •If wearing contact lens study product: Spectacle refraction of:
Exclusion Criteria
- •Current or use within 12 months of myopia management options including but not limited to
- •\-Bifocal/multifocal spectacles or contact lenses
- •\-Orthokeratology
- •\-Atropine/pirenzepine pharmacological agents
- •If contact lenses are the chosen study product: contraindications to contact lens wear, including any pre\-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids
- •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.
- •Use of or a need for concurrent category S3 and above ocular medication at enrolment.
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- •Keratoconus
- •Manifest strabismus
Outcomes
Primary Outcomes
Not specified
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