Contralateral, cross over clinical trial to assess the effect of novel and commercially available contact lenses on corneal topography
- Conditions
- Contact Lens WearCorneal TopographyContact Lens WearCorneal TopographyEye - Normal eye development and function
- Registration Number
- ACTRN12610000639022
- Lead Sponsor
- CIBA VISION Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 28
be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. If participant is a child or adolescent, a parent or legal guardian must be able to provide this consent,
- be between the ages of 18 and 45 years old inclusive
- be myopic (short sighted) -0.75D to -4.25D with astigmatism no more than -1.00 D
- 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 participant from safely wearing contact lenses;
- have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses.
- be experienced wearing contact lenses
- Pre-existing ocular irritation that would preclude contact lens fitting;
- Strabismus or amblyopia;
- Any ocular condition that may preclude safe wearing of contact lenses (e.g. active corneal infection, severe dry eye, reduced corneal sensitivity, exophthalmos/lagophthalmos, facial nerve palsy);
- Active corneal infection (bacterial, viral, fungal or protozoan) or any active ocular disease such as iritis, corneal oedema or corneal dystrophies, including anterior membrane dystrophy that would affect wearing of contact lenses;
- Any systemic disease that may adversely affect ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
- Eye surgery within 12 weeks immediately prior to enrolment for this trial;
- Previous corneal refractive surgery;
- Any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
- Contraindications to hydrogel contact lens wear;
- Worn orthokeratology lenses within the past 3 months;
- Currently enrolled in another clinical trial;
- Pregnancy (verbal report from participant will suffice).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effect of contact lenses on corneal topography in a myopic population after 8 hours and 1 week of contact lens (CL) wear.[Baseline, 1 week, 2 weeks, 3 weeks of contact lens wear]
- Secondary Outcome Measures
Name Time Method 1) To determine the effect on peripheral refraction profiles during contact lens wear with the use of a modified Shin Nippon N-Vision K5001 Autorefractor.<br>2) To determine axial length after 1 week of CL wear in a small myopic population as determined by an IOL Master optical biometer.[Baseline, 1 week, 2 weeks, 3 weeks of contact lens wear]