Age-related Macular DegenerationNCT04693702
Observational Study of Vision Improvement in Patients With Retinal Disorders
An observational study of Age-related Macular Degeneration and Diabetic Macular Edema, run by Optimal Acuity Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device. 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, Diabetic Macular Edema
- What is being tested?
- Corneal treatment by a low vision aid device
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 16 Mar 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Patients with vision impairment due to retinal disorders involving central vision loss
Who may be able to join
- - Female or male
- - Any race
- - Patient is at least 50 years old
- - Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
- - Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
- - Patient had moderate to severe baseline vision impairment with CDVA of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s)
- - Patient CDVA records are available at baseline and at 1m or longer post-Tx times
Who cannot join
- 1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.
Read the detailed description
The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.
- Being tested
- Corneal treatment by a low vision aid device
- Keywords
- Age-related macular degeneration, Diabetic macular edema
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal treatment by a low vision aid deviceDevice
Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.
| Study group | Role | What they receive |
|---|---|---|
| Age-related Macular Degeneration | Not described Receives: Device: Corneal treatment by a low vision aid device | |
| Diabetic Macular Edema | Not described Receives: Device: Corneal treatment by a low vision aid device |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDVA
Best spectacle-corrected distance visual acuity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Oct 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Optimal Acuity Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Berry, PhD, Principal investigator, Optimal Acuity Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693702
- Sponsor's protocol ID
- Retro2
- Status last verified
- Mar 2022
- First submitted
- 31 Dec 2020
- Last updated
- 20 Apr 2022
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Vision Improvement in Patients With Retinal Disorders
- ClinicalTrials.gov ID
- NCT04693702
- Acronym / sponsor ID
- Retro2
- Keywords
- Age-related macular degeneration, Diabetic macular edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Optimal Acuity CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 5 Jan 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.
The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.
Detailed description
The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age-related Macular Degeneration | – | Device: Corneal treatment by a low vision aid device |
| Diabetic Macular Edema | – | Device: Corneal treatment by a low vision aid device |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with vision impairment due to retinal disorders involving central vision loss
Key inclusion criteria (7 listed)
- - Female or male
- - Any race
- - Patient is at least 50 years old
- - Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
- - Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
Key exclusion criteria (2 listed)
- 1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational 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 |
|---|---|---|
| Corneal treatment by a low vision aid deviceNear infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision. | Device | Age-related Macular Degeneration, Diabetic Macular Edema |
Primary outcome
CDVA
Time frame: 12 months
Best spectacle-corrected distance visual acuity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- 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 J Berry, PhD principal investigator
Optimal Acuity Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Macular Degeneration and Diabetic Macular Edema, 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 20 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CDVA (time frame: 12 months). 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 20 Apr 2022.