Ocular Adaptation and Visual Performance for Accommodative Contact Lens

NCT ID: NCT02923232

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2020-03-01

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.

Conditions

Functionality of Experimental Contact Lens

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Accommodative contact lens

Intervention Type: DEVICE

Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.

Interventions

Accommodative contact lens

Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pacific University

OTHER

Sponsor Role: lead

Responsible Party

Shun-nan Yang

Director of Research at VPI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vision Performance Institute

Forest Grove, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

OFV-S1

Identifier Type: -

Identifier Source: org_study_id