None listed
Conditions
Brief summary
To cross-validate the second generation EyeMapper (EyeMapper Gen 2) against the previously validated prototype instrument, EyeMapper Gen 1.
Interventions
Participants will be required to attend one visit. For the EyeMapper Gen 2 instrument, the participant’s head will be positioned on a chin rest and look at an internal fixation target. No contact will be made with the eye at any time. Following alignment, measurement is taken. Five consecutive measurements will be performed per instrument. Overall duration of measurements will be 10 minutes. The participants cross over measurements, not treatments so although this is a crossover trial there is n
Participants will be required to attend one visit. For the EyeMapper Gen 2 instrument, the participant’s head will be positioned on a chin rest and look at an internal fixation target. No contact will be made with the eye at any time. Following alignment, measurement is taken. Five consecutive measurements will be performed per instrument. Overall duration of measurements will be 10 minutes. The participants cross over measurements, not treatments so although this is a crossover trial there is no need for a wash out as the measurement is non invasive. The measurements will occur one after the other.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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, male or female. Willing to comply with the clinical trial visit schedule as directed by the Investigator. Have ocular health findings considered to be “normal”.
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 surgery. Rigid gas Permeable or orthokeratology lens wear in the past month. Known allergy or intolerance to ingredients in any of the clinical trial products. Currently enrolled in another clinical trial. Pregnancy.
Outcome results
None listed