Dry Age-related Macular DegenerationNCT04875234
Vision Improvement for Legally Blind Dry AMD Patients
An observational study of Dry Age-related Macular Degeneration and Vision Impairment and Blindness, run by Optimal Acuity Corporation.
Trial summary
This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Age-related Macular Degeneration, Vision Impairment and Blindness
- What is being tested?
- Clear-K Low Vision Aid Treatment
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with dry age-related macular degeneration an legal blindness in one or both eyes
Who may be able to join
None listed.
Who cannot join
- Visually significant cataract in the study eye
- Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye
- Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye
- Previous corneal surgery in the study eye
- 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 may confound the outcome of the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vision Improvement for Legally Blind Dry Age-Related Macular Degeneration Patients
This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.
Read the detailed description
This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.
- Being tested
- Clear-K Low Vision Aid Treatment
- Keywords
- AMD, vision impairment, blindness
- Medical subject headings
- Vision Disorders, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear-K Low Vision Aid TreatmentDevice
A Clear-K Low Vision Aid Device is used to produce small corneal shape and refraction changes in order to redirect light onto functional areas of the retina.
| Study group | Role | What they receive |
|---|---|---|
| Legally Blind Dry AMD Patients | Legally Blind Dry AMD Patients with either unilateral or bilateral blindness Receives: Device: Clear-K Low Vision Aid Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best spectacle-corrected distance visual acuity (BCDVA)
BCDVA measured using ETDRS eye charts
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study startJan 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optimal Acuity Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Berry, PhD, Principal investigator, Optimal Acuity Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875234
- Sponsor's protocol ID
- Retro3
- Status last verified
- Apr 2022
- First submitted
- 3 May 2021
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
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 Legally Blind Dry Age-Related Macular Degeneration Patients
- ClinicalTrials.gov ID
- NCT04875234
- Acronym / sponsor ID
- Retro3
- Keywords
- AMD, vision impairment, blindness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Optimal Acuity CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 May 2021 (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.
This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.
Detailed description
This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Legally Blind Dry AMD Patients | – | Device: Clear-K Low Vision Aid TreatmentLegally Blind Dry AMD Patients with either unilateral or bilateral blindness |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dry age-related macular degeneration an legal blindness in one or both eyes
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Visually significant cataract in the study eye
- Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye
- Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye
- Previous corneal surgery in the study eye
- 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 may confound the outcome of the study
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 |
|---|---|---|
| Clear-K Low Vision Aid TreatmentA Clear-K Low Vision Aid Device is used to produce small corneal shape and refraction changes in order to redirect light onto functional areas of the retina. | Device | Legally Blind Dry AMD Patients |
Primary outcome
Best spectacle-corrected distance visual acuity (BCDVA)
Time frame: 12 months post-treatment
BCDVA measured using ETDRS eye charts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Michael Berry, PhD principal investigator
Optimal Acuity Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Age-related Macular Degeneration and Vision Impairment and Blindness, run by Optimal Acuity Corporation.
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 0 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: opening soon, 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Berry, PhD (831-869-1384, 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 (BCDVA) (time frame: 12 months post-treatment). 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.