GlaucomaOCTNCT03505567
Study to Compare Kowa OCT Bi-μ and the Optovue iVue 100
A study testing KOWA OCT Bi-µ and Optovue iVue 100 in people with Glaucoma and Retinal Disease, run by Kowa Research Institute, Inc. at 1 site in United States.
Trial summary
This study is a prospective comparative study to gather pilot agreement and precision data in normal subjects, subjects with glaucoma, and subjects with retinal disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Retinal Disease, Healthy
- What is being tested?
- KOWA OCT Bi-µ and Optovue iVue 100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2018to 1 Sep 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with normal eye examinations (without pathology other than cataract) in one or both eyes on the date of the study visit;
- Subjects with intraocular pressure (IOP) ≤ 21 mmHg in the normal eye(s) on the date of the study visit; and
- Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or better in the normal eye(s) on the date the study visit.
- Subjects who have been diagnosed with glaucoma in the glaucoma study eye(s), with optic nerve damage as evidenced by either of the following optic disc or retinal nerve fiber layer structural abnormalities observed via fundus exam during the study visit:
- Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; or
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue;
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- Subjects with a current BSCVA of 20/40 or better in the glaucoma study eye(s) on the date of the visit; and
- History of visual field defects within the previous two (2) months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage based on at least one of the following findings:
- On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; and
- Glaucoma hemi-field test "outside normal limits."
- Subjects with current IOP ≤ 21 mmHg in the retinal disease study eye(s) on the day of the study visit;
- Subjects with a current BSCVA of 20/400 or better in the retinal disease study eye(s) at the study visit; and
- Subjects diagnosed with retinal pathology including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, and others in the retinal disease study eye(s) as confirmed within the past six (6) months.
Who cannot join
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects with any current ocular pathology other than cataract in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit;
- Subjects with current narrow anterior chamber drainage angle in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit; and
- Subjects with a history of leukemia, dementia or multiple sclerosis.
- Subjects unable to tolerate ophthalmic imaging;
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- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects with at least one Humphrey Field Analyzer (HFA) visual field (24-2 SITA Standard, white on white) measured on the day of the study visit, or within the previous two (2) months from the study visit with unreliable results, defined as fixation losses > 20%, or false positives > 33%, or false negatives > 33% in the glaucoma study eye(s);
- Subjects with any current ocular pathology except glaucoma in the glaucoma study eye(s), as determined by self-report and/or investigator assessment on the day of the study visit; and
- Subjects with a history of leukemia, dementia or multiple sclerosis.
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects with glaucoma or any ocular pathology other than retinal pathology (e.g. cornea pathology) in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit;
- Subjects with current narrow anterior chamber drainage angle in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit; and
- Subjects with a history of leukemia, dementia or multiple sclerosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: Pilot Comparative Study of the Kowa OCT Bi-μ and the Optovue iVue 100
This study is a prospective comparative study to gather pilot agreement and precision data in normal subjects, subjects with glaucoma, and subjects with retinal disease.
- Conditions
- Glaucoma, Retinal Disease, Healthy
- Being tested
- KOWA OCT Bi-µ, Optovue iVue 100
- Medical subject headings
- Glaucoma, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOWA OCT Bi-µDevice
Non-contact, ultra-high resolution ophthalmic imaging system for fundus imaging and axial cross-sectional and three-dimensional imaging of retinal structures.
Optovue iVue 100Device
U.S. Food and Drug Administration (FDA) cleared and commercially available Optovue iVue 100
| Study group | Role | What they receive |
|---|---|---|
| Random Sequenced Interventions | Other | Participants from three condition groups (normal, glaucoma, retinal disease) assigned two interventions (Kowa OCT Bi-μ and the Optovue iVue 100) under random sequence assignments. Receives: Device: KOWA OCT Bi-µ; Device: Optovue iVue 100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare KOWA OCT Bi-μ and Optovue iVue 100
- Full retinal thickness [Early Treatment Diabetic Retinopathy Study (ETDRS) Grid]
- Full retinal thickness (Manual Measurement)
- Retinal nerve fiber layer thickness
- Ganglion cell complex thickness
- Full retinal thickness map
Measured: 1-2 days
Secondary outcomes (1)
Safety: Evaluate any adverse events found during the clinical study
Evaluate any adverse events found during the clinical study
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start21 Apr 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible participants assigned two interventions under random sequence assignments.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Hosford, MD, Ph.D, Study director, Kowa Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505567
- Sponsor's protocol ID
- RT1-01US
- Acronym
- OCT
- Status last verified
- Sep 2018
- First submitted
- 16 Apr 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Comparative Study of the Kowa OCT Bi-μ and the Optovue iVue 100
- ClinicalTrials.gov ID
- NCT03505567
- Acronym / sponsor ID
- OCT / RT1-01US
- Conditions
- Glaucoma, Retinal Disease, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 23 Apr 2018 (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 study is a prospective comparative study to gather pilot agreement and precision data in normal subjects, subjects with glaucoma, and subjects with retinal disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible participants assigned two interventions under random sequence assignments.
| Arm | Type | Receives |
|---|---|---|
| Random Sequenced Interventions | Other | Device: KOWA OCT Bi-µ, Device: Optovue iVue 100Participants from three condition groups (normal, glaucoma, retinal disease) assigned two interventions (Kowa OCT Bi-μ and the Optovue iVue 100) under random sequence assignments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with normal eye examinations (without pathology other than cataract) in one or both eyes on the date of the study visit;
- Subjects with intraocular pressure (IOP) ≤ 21 mmHg in the normal eye(s) on the date of the study visit; and
- Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or better in the normal eye(s) on the date the study visit.
- Subjects who have been diagnosed with glaucoma in the glaucoma study eye(s), with optic nerve damage as evidenced by either of the following optic disc or retinal nerve fiber layer structural abnormalities observed via fundus exam during the study visit:
- Subjects with a current BSCVA of 20/40 or better in the glaucoma study eye(s) on the date of the visit; and
Key exclusion criteria (15 listed)
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects with any current ocular pathology other than cataract in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit;
- Subjects with current narrow anterior chamber drainage angle in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit; and
- Subjects with a history of leukemia, dementia or multiple sclerosis.
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 |
|---|---|---|
| KOWA OCT Bi-µNon-contact, ultra-high resolution ophthalmic imaging system for fundus imaging and axial cross-sectional and three-dimensional imaging of retinal structures. | Device | Random Sequenced Interventions |
| Optovue iVue 100U.S. Food and Drug Administration (FDA) cleared and commercially available Optovue iVue 100 | Device | Random Sequenced Interventions |
Primary outcome
Compare KOWA OCT Bi-μ and Optovue iVue 100
Time frame: 1-2 days
1. Full retinal thickness [Early Treatment Diabetic Retinopathy Study (ETDRS) Grid] 2. Full retinal thickness (Manual Measurement) 3. Retinal nerve fiber layer thickness 4. Ganglion cell complex thickness 5. Full retinal thickness map
1 secondary outcome
Safety: Evaluate any adverse events found during the clinical study
Time frame: 1-2 days
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 10 Sep 2018.
- 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.
David Hosford, MD, Ph.D study director
Kowa Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOWA OCT Bi-µ and Optovue iVue 100 in people with Glaucoma and Retinal Disease, run by Kowa Research Institute, Inc. 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 13 inclusion and 15 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 10 Sep 2018. 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?
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?
Compare KOWA OCT Bi-μ and Optovue iVue 100 (time frame: 1-2 days). 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 10 Sep 2018.