Ocular Adaptation and Visual Performance for Accommodative Contact Lens (ACL)

Pacific University

Status: Terminated

Conditions: Functionality of Experimental Contact Lens

Treatments: Device: Accommodative contact lens

Study type: Interventional

Funder types: Other

Identifiers

NCT02923232

OFV-S1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Accommodative contact lens

Experimental group

Description:

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.

Treatment:

Device: Accommodative contact lens