Functionality of Experimental Contact Lens
Conditions
Keywords
Contact lens; Accommodation; Visual performance
Brief summary
Presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) will be recruited to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles.
Detailed description
In the proposed study we plan to recruit presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles. These are similar to the typical examinations conducted for regular contact lens wearers. Results of this testing will be used to evaluate the efficacy of test lenses and to provide additional information for revision of test lenses. If shown to provide adequate eye comfort and intended vision correction, this lens design has the potential of allowing tens of millions of presbyopes to adapt to contact lenses and significantly improve their vision and well-being.
Interventions
DEVICEAccommodative contact lens
Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.
Sponsors
Pacific University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Be between 40 and 65 years of age. * Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes. * Have pupil diameter in regular lighting ≥ 2.5 mm. * Willing and able to wear multifocal contact lenses in both eyes. * Have a current optical prescription (obtained less than 2 years ago). * Have spherical equivalent correction equal to or higher than -1.00 Diopter and equal to or less than +0.50 Diopter. * Have cylindrical correction equal to less than 0.50 Diopter.
Exclusion criteria
* Have no prismatic correction. * Without any eye infection, inflammation, disease, or abnormality that contraindicates contact lens wear within the past 6 months. * No clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration) * Have no photosensitive disorders, including migraine and seizure. * Have no binocular dysfunction, including amblyopia, strabismus, and other binocular diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Refractive Power | 30 mins of wearing; non-dispensing. | Participants will wear the test lens and look at different downsize angles. The refractive power of the lens/eye combination will be measured with an open-field auto refractor. |
| Visual Acuity at 20 Degree Downsize Angles | 30 mins of wearing; non-dispensing. | The resultant visual acuity at near at this down-gaze angle will be measured. This is achieved by having the subjects holding a new acuity chart at 40 cm distance, their heads upright and perpendicular to the ground, and their gazes rotated downward 20 degrees where the chart was located. The subjects then read out the optotypes (letters) on the chart to a size they cannot no only identify the letters. The lines of letters with which all letters can be identified is recorded as the corresponding level of acuity. |
Countries
United States
Participant flow
Recruitment details
This study involved few participants recruited from Pacific University and designated clinics. It went through 3 iterations in lens design changes and less than 10 subjects in each iteration.
Pre-assignment details
Subjects were recruited in 3 separate iterations. They were not assigned to different groups, and were tested with the same test lens with minor modification. This is considered a phase 1 study.
Participants by arm
| Arm | Count |
|---|---|
| Accommodative Contact Lens The accommodative contact lens is composed of traditional hydrogel lens material but has an internal cavity to allow lens deformation that increases its refractive power at an downward angle.
Accommodative contact lens: Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles. | 52 |
| Accommodative Contact Lens The accommodative contact lens is composed of traditional hydrogel lens material but has an internal cavity to allow lens deformation that increases its refractive power at an downward angle.
Accommodative contact lens: Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles. | 52 |
| Total | 104 |
Baseline characteristics
| Characteristic | Accommodative Contact Lens |
|---|---|
| Age, Customized Age at the entrance date | 52.6 year STANDARD_DEVIATION 14.2 |
| Monocular visual acuity | .4 logMAR STANDARD_DEVIATION 0.23 |
| Sex: Female, Male Female | 32 eyes |
| Sex: Female, Male Male | 20 eyes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
Monocular Refractive Power
Participants will wear the test lens and look at different downsize angles. The refractive power of the lens/eye combination will be measured with an open-field auto refractor.
Time frame: 30 mins of wearing; non-dispensing.
Population: Presbyopes who require distance optical correction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Accommodative Contact Lens | Monocular Refractive Power | -1.5 Diopter | Standard Deviation 2.42 |
Primary
Visual Acuity at 20 Degree Downsize Angles
The resultant visual acuity at near at this down-gaze angle will be measured. This is achieved by having the subjects holding a new acuity chart at 40 cm distance, their heads upright and perpendicular to the ground, and their gazes rotated downward 20 degrees where the chart was located. The subjects then read out the optotypes (letters) on the chart to a size they cannot no only identify the letters. The lines of letters with which all letters can be identified is recorded as the corresponding level of acuity.
Time frame: 30 mins of wearing; non-dispensing.
Population: Presbyopes who require distance optical correction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Accommodative Contact Lens | Visual Acuity at 20 Degree Downsize Angles | 0.24 logMAR | Standard Deviation 0.22 |