A short-term evaluation of the accommodative responses of 6 contact lenses for myopia control and a control lens.
- Conditions
- MyopiaOcular AccommodationEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12618001790235
- Lead Sponsor
- Brien Holden Vision Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 57
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Be between 18-40 years old, 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.
• Be myopic with less than or equal to 1.00 D of cylindrical power in either eye.
• Be correctable to at least 0.20 logMAR in each eye with single vision contact lenses.
• 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, Sjögrens 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 enrollment.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accommodative response as measured on an open-field auto-refractor.[All 6 assessment visits]
- Secondary Outcome Measures
Name Time Method Heterophoria: This will be assessed with distance and near Modified Thorington technique at 3m and 40cm respectively.[All 6 assessment visits];Near monocular accommodative facility: This will be assessed with +/- 2D flip spheres at 40cm, with the unmeasured eye occluded. [All 6 assessment visits]