Functionality of Experimental Contact LensACLNCT02923232
Ocular Adaptation and Visual Performance for Accommodative Contact Lens
A study testing Accommodative contact lens in people with Functionality of Experimental Contact Lens, run by Pacific University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functionality of Experimental Contact Lens
- What is being tested?
- Accommodative contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vision Performance Institute
Forest Grove, Oregon, 97116
About this study
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.
Read the 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.
- Being tested
- Accommodative contact lens
- Keywords
- Contact lens; Accommodation; Visual performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accommodative contact lensDevice
Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accommodative contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 mins of wearing; non-dispensing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startNov 2014
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Funding organization requested to stop the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functionality of Experimental Contact LensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shun-nan Yang, Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923232
- Sponsor's protocol ID
- OFV-S1
- Acronym
- ACL
- Status last verified
- Apr 2023
- First submitted
- 29 Sep 2016
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Adaptation and Visual Performance for Accommodative Contact Lens
- ClinicalTrials.gov ID
- NCT02923232
- Acronym / sponsor ID
- ACL / OFV-S1
- Keywords
- Contact lens; Accommodation; Visual performance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding organization requested to stop the study
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pacific UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accommodative contact lens | Experimental | Device: Accommodative contact lensThe 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accommodative contact lensDifferent downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles. | Device | Accommodative contact lens |
Primary outcome
Monocular Refractive Power
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.
Visual Acuity at 20 Degree Downsize Angles
Time frame: 30 mins of wearing; non-dispensing.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accommodative contact lens in people with Functionality of Experimental Contact Lens, run by Pacific University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular Refractive Power (time frame: 30 mins of wearing; non-dispensing.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.