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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accommodative contact lens | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accommodative contact lens | Device | Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 mins of wearing; non-dispensing. |
| 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. | 30 mins of wearing; non-dispensing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Performance Institute | Forest Grove | Oregon | 97116 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Accommodative Contact Lens | This was a study involving only the test contact lens. There is no control condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Presbyopes
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Presbyopes who require distance optical correction | Posted | Mean | Standard Deviation | Diopter | 30 mins of wearing; non-dispensing. | eyes | eyes |
|
|
Duration of wear, usually no more than 30 mins.
This is a non-prescription study involving only temporarily worn contact lens for a period of 30 mins during which refractive error and acuity of tested eyes were measured. As such, there is no expected risk in mortality and serious adverse effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Accommodative Contact Lens | This was a study involving only the test contact lens. There is no control condition. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shun-nan Yang | Pacific University | 5033522852 | shunnan.yang@pacificu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 1, 2017 | May 22, 2022 | Prot_ICF_000.pdf |
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| eyes |
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| year |
| Participants |
|
|
| Sex: Female, Male | Count of Units | eyes | eyes |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Monocular visual acuity | Subjects wore no optical correction and their distance monocular acuity was assessed. | Mean | Standard Deviation | logMAR | eyes |
|
|
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| eyes |
|
|
| 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. | Presbyopes who require distance optical correction | Posted | Mean | Standard Deviation | logMAR | 30 mins of wearing; non-dispensing. |
|
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| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
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