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

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.

Study Overview

• Status: Terminated
• Conditions: Functionality of Experimental Contact Lens
• Intervention / Treatment: Device: Accommodative contact lens

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Forest Grove, Oregon, United States, 97116
      • Vision Performance Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Accommodative contact lens; Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Pacific University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: October 2, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Contact lens; Accommodation; Visual performance
• Other Study ID Numbers: OFV-S1