NCT02923232

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

5.3 years

First QC Date

September 29, 2016

Results QC Date

September 26, 2022

Last Update Submit

April 28, 2023

Conditions

Functionality of Experimental Contact Lens

Keywords

Contact lens; Accommodation; Visual performance

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (1)

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.

Device: Accommodative contact lens

Interventions

Accommodative contact lensDEVICE

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

Accommodative contact lens

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vision Performance Institute

Forest Grove, Oregon, 97116, United States

Location

Results Point of Contact

Title
Dr. Shun-nan Yang
Organization
Pacific University
shunnan.yang@pacificu.edu
5033522852

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research at VPI

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 4, 2016

Study Start

November 1, 2014

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

May 3, 2023

Results First Posted

May 3, 2023

Record last verified: 2023-04

Locations

US(1)