Ametropia, Astigmatism
Conditions
Brief summary
The aim of this study is to evaluate the agreement between subjective and objective toric lens prescriptions.
Detailed description
To evaluate agreement between subjective and objective optimized toric contact lens prescriptions.
Interventions
DEVICELens 1 ( stenfilcon A )
15 minutes of daily wear
DEVICELens 2 ( comfilcon A )
15 minutes of daily wear
Sponsors
CooperVision International Limited (CVIL)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They are at least 18 years of age. 2. They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent. 3. They have spherical refractive error at the corneal plane between +4.00 to -7.00DS 4. They have refractive astigmatism at the corneal plane of 0.75 to 2.25DC in one eye. 5. They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye 6. They are a current soft contact lens wearer or have previous experience of successful soft contact lens wear in the past 3 years.
Exclusion criteria
1. Is participating in any concurrent clinical or research trial. 2. They have an ocular disorder which would normally contra-indicate contact lens wear. 3. They have a systemic disorder which would normally contra-indicate contact lens wear. 4. They are pseudophakic or aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective assessment of optimization of Toric lenses | At the End of Baseline 15 minutes of daily wear | Proportion of eyes in which the optimized toric lens cylinder axis determined by the subjective method agrees with that determined by the objective method within ±10 degrees (measured at a single time point). |
Countries
United States
Contacts
CONTACTKelly Voltz
Outcome results
None listed