Ocular Adaptation and Visual Performance for Accommodative Contact Lens

Functionality of Experimental Contact Lens Clinical Trial

— ACL  

Official title:

Ocular Adaptation and Visual Performance for Accommodative Contact Lens

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02923232
• Other study ID #: OFV-S1
• Status: Terminated
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2023
• Source: Pacific University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Functionality of Experimental Contact Lens

Intervention

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.

Locations

Country	Name	City	State
United States	Vision Performance Institute	Forest Grove	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Pacific University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.