Age-related Macular DegenerationAMDNCT04268836
Vision Improvement for Patients With Age-Related Macular Degeneration
A study testing Optimal Acuity Clear-K® Low Vision Aid System treatment in people with Age-related Macular Degeneration, run by Optimal Acuity Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve vision for patients with age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Optimal Acuity Clear-K® Low Vision Aid System treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Any race
- Patient is at least 50 years old.
- Patient has diagnosed dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination by a retina specialist; the full ocular examination, including optical coherence tomography (OCT) measurements, should be part of the patient's file.
- Wet AMD eyes should have an inactive disease state (i.e., there is no clinical or OCT evidence of wet AMD disease activity).
- Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated..
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- Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
- Patient has moderate to severe vision impairment due to dry age-related macular degeneration with best spectacle-corrected distance visual acuity (CDVA) of 20/80 or worse (decimal = 0.25 or less; logMAR ≥ 0.60) in the better eye.
- Patient has CDVA of 20/400 or better (decimal = 0.05 or greater; logMAR ≤ 1.30) in the worse eye.
- Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires) in both eyes.
- Patient is not a contact lens (CL) wearer.
- Patient is willing and able to comply with all examinations.
- Patient must be competent to sign an informed consent form before study entry.
Who cannot join
- Corneal disease or disorder in either eye;
- Corneal topographic astigmatism greater than 2.00 D (mean value within 3.0 mm optical zone);
- Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola (as evaluated by optical coherence tomography);
- Potential Visual Acuity (PVA) in both eyes that is not improved by at least three lines compared to CDVA;
- Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma; and
- Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
1929 Bayview Ave., Suite 117
Toronto, Ontario, M4G 3E8
Samuel Markowitz, MD, FRCSC, 4165315425, snm1@rogers.com
Samuel N Markowitz, MD, FRCSC
About this study
The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve vision for patients with age-related macular degeneration.
Read the detailed description
The Optimal Acuity Clear-K® Low Vision Aid System treats corneas with near infrared light in order to change the modulus of small volumes of anterior stromal corneal tissue. The change of modulus produces a change of corneal stiffness and shape that modifies the distribution of light onto the retina. Light rays are redirected from dysfunctional areas of the retina that have been damaged by age-related macular degeneration (AMD) to functional areas of the retina, thereby improving patient vision.
200 AMD patients meeting eligibility requirements will be treated. The study will record and analyze pre-treatment (Tx) and post-Tx examinations with follow-up extending to 24 months post-Tx. Analysis will include descriptive statistics and measures of correlation between outcomes and patient baseline characteristics.
The primary objective of the study is to evaluate the safety and effectiveness of Clear-K® treatment in providing vision improvement to AMD patients.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Optimal Acuity Clear-K® Low Vision Aid System treatment
- Keywords
- dry AMD, wet AMD, neovascular AMD, age-related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal Acuity Clear-K® Low Vision Aid System treatmentDevice
The treatment involves irradiation of the cornea with low energy light in a treatment pattern that produces corneal shape change.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients will be treated by the Optimal Acuity Clear-K Low Vision Aid System. Receives: Device: Optimal Acuity Clear-K® Low Vision Aid System treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx
CDVA will be measured using ETDRS letter scoring both pre-Tx and post-Tx with follow-up to 24 months post-Tx
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Visual Function Questionnaire (VFQ)-25 quality of life assessment
The VFQ-25 instrument will be used to assess patient quality of life measures.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start9 Jan 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies 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
- Model description
- Prospective, non-randomized, unmasked clinical study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optimal Acuity Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bochner Eye Institute
- Responsible party
- Sponsor
- Investigators
- Michael Berry, PhD, Study director, Optimal Acuity Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268836
- Sponsor's protocol ID
- OAC #001
- Acronym
- AMD
- Status last verified
- Apr 2022
- First submitted
- 16 Jan 2018
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision Improvement for Patients With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04268836
- Acronym / sponsor ID
- AMD / OAC #001
- Conditions
- Age-related Macular Degeneration
- Keywords
- dry AMD, wet AMD, neovascular AMD, age-related macular degeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Optimal Acuity CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Bochner Eye Institute
- Study start
- 9 Jan 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the Optimal Acuity Clear-K® Low Vision Aid System provides a safe and effective treatment to improve vision for patients with age-related macular degeneration.
Detailed description
The Optimal Acuity Clear-K® Low Vision Aid System treats corneas with near infrared light in order to change the modulus of small volumes of anterior stromal corneal tissue. The change of modulus produces a change of corneal stiffness and shape that modifies the distribution of light onto the retina. Light rays are redirected from dysfunctional areas of the retina that have been damaged by age-related macular degeneration (AMD) to functional areas of the retina, thereby improving patient vision.
200 AMD patients meeting eligibility requirements will be treated. The study will record and analyze pre-treatment (Tx) and post-Tx examinations with follow-up extending to 24 months post-Tx. Analysis will include descriptive statistics and measures of correlation between outcomes and patient baseline characteristics.
The primary objective of the study is to evaluate the safety and effectiveness of Clear-K® treatment in providing vision improvement to AMD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, unmasked clinical study
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Optimal Acuity Clear-K® Low Vision Aid System treatmentPatients will be treated by the Optimal Acuity Clear-K Low Vision Aid System. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or Female
- Any race
- Patient is at least 50 years old.
- Patient has diagnosed dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination by a retina specialist; the full ocular examination, including optical coherence tomography (OCT) measurements, should be part of the patient's file.
- Wet AMD eyes should have an inactive disease state (i.e., there is no clinical or OCT evidence of wet AMD disease activity).
Key exclusion criteria (6 listed)
- Corneal disease or disorder in either eye;
- Corneal topographic astigmatism greater than 2.00 D (mean value within 3.0 mm optical zone);
- Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola (as evaluated by optical coherence tomography);
- Potential Visual Acuity (PVA) in both eyes that is not improved by at least three lines compared to CDVA;
- Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma; and
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 |
|---|---|---|
| Optimal Acuity Clear-K® Low Vision Aid System treatmentThe treatment involves irradiation of the cornea with low energy light in a treatment pattern that produces corneal shape change. | Device | Treatment arm |
Primary outcome
Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx
Time frame: Through study completion, an average of 2 years
CDVA will be measured using ETDRS letter scoring both pre-Tx and post-Tx with follow-up to 24 months post-Tx
1 secondary outcome
Visual Function Questionnaire (VFQ)-25 quality of life assessment
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Michael Berry, PhD study director
Optimal Acuity Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal Acuity Clear-K® Low Vision Aid System treatment in people with Age-related Macular Degeneration, run by Optimal Acuity Corporation at 1 site in Canada.
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 13 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Mar 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Berry, PhD (8318691384, mberry177@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best spectacle-corrected distance visual acuity (CDVA) changes from baseline to 24 months post-Tx (time frame: Through study completion, an average of 2 years). 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 22 Mar 2023.