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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923232
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Shun-nan Yang, Pacific University

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.

Condition or disease Intervention/treatment Phase
Functionality of Experimental Contact Lens Device: Accommodative contact lens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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.




Primary Outcome Measures :
  1. refractive power of contact lens [ Time Frame: 30 mins of wearing; non-dispensing. ]
    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.

  2. visual acuity at different downsize angles [ Time Frame: 30 mins of wearing; non-dispensing. ]
    The resultant visual acuity at near at these downgaze angles will be measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923232


Contacts
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Contact: Shun-nan Yang, PhD 15033522852 shunnan.yang@pacificu.edu

Locations
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United States, Oregon
Vision Performance Institute Recruiting
Forest Grove, Oregon, United States, 97116
Contact: Shun-nan Yang, PhD    503-352-2852    shunnan.yang@pacificu.edu   
Principal Investigator: Shun-nan Yang, PhD         
Sponsors and Collaborators
Pacific University

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Responsible Party: Shun-nan Yang, Director of Research at VPI, Pacific University
ClinicalTrials.gov Identifier: NCT02923232    
Other Study ID Numbers: OFV-S1
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Keywords provided by Shun-nan Yang, Pacific University:
Contact lens; Accommodation; Visual performance