Age-Related (Dry) Macular DegenerationNCT02540148
Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
A study testing Nova Oculus™ Micro-current electrical stimulation in people with Age-Related (Dry) Macular Degeneration, run by The Eye Machine Canada Inc. at 1 site in Canada.
Trial summary
Assess the effectiveness of externally applied micro current electrical stimulation on improving the ETDRS visual acuity in subjects with vision loss from dry age-related macular degeneration (AMD) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related (Dry) Macular Degeneration
- What is being tested?
- Nova Oculus™ Micro-current electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2019to 30 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fifty years of age or older
- Male or female
- Best-corrected vision 20/50 to 20/200 for each enrolled eye
- Confirmed diagnosis of dry AMD
- Vision loss attributable to dry AMD
- Subjects must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent
Who cannot join
- Any visually significant retinal pathology other than dry AMD
- Previous intravitreal injection
- Seizure disorders
- Previous vitreo-retinal surgery. (ERM, PPV, RD etc)
- Dense cataract
- Eyelid pathology at the treatment sites
Show all 14Show fewer
- Glaucoma patients with a visual field mean defect of greater than 10dB on Humphrey visual field testing
- Glasses are up to date (prescription <1 year old)
- Any prior electrical micro-stimulation treatment to the eyes
- Poor general health
- Active cancer
- Life expectancy less than 12 months
- Non-ambulatory
- Not considered suitable for participation for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Assess the effectiveness of externally applied micro current electrical stimulation on improving the ETDRS visual acuity in subjects with vision loss from dry age-related macular degeneration (AMD)
Read the detailed description
Micro-current electrical stimulation will be used to treat /each eye in a group of subjects with dry AMD. 60 subjects will be randomly divided into two groups. A ratio of 1:3 will be maintained between control and the experimental groups. In the treatment group, subjects will undergo a treatment session to the enrolled eyes daily for three days during week 1, followed by a single treatment session during weeks 2, 14 and 26 with the Nova Oculus device. A second group of subjects will act as the control group. This group will undergo sham treatment at the same treatment intervals with a non-functional Nova Oculus device. ETDRS visual acuity will be performed on all subjects at enrollment prior to each treatment and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the ETDRS visual acuity of subjects with dry AMD will be determined.
- Conditions
- Age-Related (Dry) Macular Degeneration
- Being tested
- Nova Oculus™ Micro-current electrical stimulation, Nova Oculus™ Micro-current electrical stimulation - Sham treatment
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nova Oculus™ Micro-current electrical stimulationDevice
Active treatment with transpalpebral micro-current electrical stimulation device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26.
Nova Oculus™ Micro-current electrical stimulation - Sham treatmentDevice
Non-active treatment with transpalpebral micro-current electrical stimulation SHAM device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Patients will be fully consented before the start of the study. In the treatment group, subjects will undergo a treatment session to the enrolled eyes for three days during Week 1, followed by a single treatment session during Weeks 2, 14 and 26 with the Nova Oculus device. A treatment session is 15 minutes of treatment on each closed eye lid for a total of 30 minutes. ETDRS visual acuity will be performed on all subjects at enrollment (prior to the first treatment), prior to each treatment session, and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the visual acuity of subjects with dry AMD will be determined.e. Receives: Device: Nova Oculus™ Micro-current electrical stimulation |
| Non-active treatment | Sham comparator | A second group of subjects will act as the control group. This group will undergo sham treatment to the enrolled eyes at the same intervals as the treatment group (Weeks 2, 14 and 26), but with a nonfunctional Nova Oculus device. A treatment session is 15 minutes of treatment on each closed eye lid for a total of 30 minutes. ETDRS visual acuity will be performed on all subjects at enrollment (prior to the first treatment), prior to each treatment session, and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the visual acuity of subjects with dry AMD will be determined. Receives: Device: Nova Oculus™ Micro-current electrical stimulation - Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start15 Nov 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related (Dry) 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Eye Machine Canada Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Parkinson, MD, Principal investigator, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540148
- Sponsor's protocol ID
- NO001D
- Status last verified
- Aug 2021
- First submitted
- 1 Sep 2015
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Parkinson KM, Sayre EC, Tobe SW. Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation. Int J Retina Vitreous. 2023 Jun 18;9(1):36. doi: 10.1186/s40942-023-00471-y.
PubMed 37331928
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02540148
- Acronym / sponsor ID
- NO001D
- Conditions
- Age-Related (Dry) Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Eye Machine Canada Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Sep 2015 (estimated)
- 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.
Assess the effectiveness of externally applied micro current electrical stimulation on improving the ETDRS visual acuity in subjects with vision loss from dry age-related macular degeneration (AMD)
Detailed description
Micro-current electrical stimulation will be used to treat /each eye in a group of subjects with dry AMD. 60 subjects will be randomly divided into two groups. A ratio of 1:3 will be maintained between control and the experimental groups. In the treatment group, subjects will undergo a treatment session to the enrolled eyes daily for three days during week 1, followed by a single treatment session during weeks 2, 14 and 26 with the Nova Oculus device. A second group of subjects will act as the control group. This group will undergo sham treatment at the same treatment intervals with a non-functional Nova Oculus device. ETDRS visual acuity will be performed on all subjects at enrollment prior to each treatment and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the ETDRS visual acuity of subjects with dry AMD will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Device: Nova Oculus™ Micro-current electrical stimulationPatients will be fully consented before the start of the study. In the treatment group, subjects will undergo a treatment session to the enrolled eyes for three days during Week 1, followed by a single treatment session during Weeks 2, 14 and 26 with the Nova Oculus device. A treatment session is 15 minutes of treatment on each closed eye lid for a total of 30 minutes. ETDRS visual acuity will be performed on all subjects at enrollment (prior to the first treatment), prior to each treatment session, and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the visual acuity of subjects with dry AMD will be determined.e. |
| Non-active treatment | Sham comparator | Device: Nova Oculus™ Micro-current electrical stimulation - Sham treatmentA second group of subjects will act as the control group. This group will undergo sham treatment to the enrolled eyes at the same intervals as the treatment group (Weeks 2, 14 and 26), but with a nonfunctional Nova Oculus device. A treatment session is 15 minutes of treatment on each closed eye lid for a total of 30 minutes. ETDRS visual acuity will be performed on all subjects at enrollment (prior to the first treatment), prior to each treatment session, and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the visual acuity of subjects with dry AMD will be determined. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fifty years of age or older
- Male or female
- Best-corrected vision 20/50 to 20/200 for each enrolled eye
- Confirmed diagnosis of dry AMD
- Vision loss attributable to dry AMD
Key exclusion criteria (14 listed)
- Any visually significant retinal pathology other than dry AMD
- Previous intravitreal injection
- Seizure disorders
- Previous vitreo-retinal surgery. (ERM, PPV, RD etc)
- Dense cataract
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 |
|---|---|---|
| Nova Oculus™ Micro-current electrical stimulationActive treatment with transpalpebral micro-current electrical stimulation device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26. | Device | Active Treatment |
| Nova Oculus™ Micro-current electrical stimulation - Sham treatmentNon-active treatment with transpalpebral micro-current electrical stimulation SHAM device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26. | Device | Non-active treatment |
Primary outcome
Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment.
Time frame: 26 weeks
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 17 Aug 2021.
- Derived from this study: PubMed 37331928Parkinson KM, Sayre EC, Tobe SW. Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation. Int J Retina Vitreous. 2023 Jun 18;9(1):36. doi: 10.1186/s40942-023-00471-y.
- 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.
Kevin Parkinson, MD principal investigator
Independent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nova Oculus™ Micro-current electrical stimulation in people with Age-Related (Dry) Macular Degeneration, run by The Eye Machine Canada Inc. 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 6 inclusion and 14 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 17 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02540148, which also lists 1 linked publication.
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 17 Aug 2021.