Normal SubjectNCT06496763
Assessment of an Automated Optical Coherence Tomography and Camera : Effectiveness of Vision-700
An observational study of Normal Subject and Glaucoma, run by Crystalvue Medical Coporation at 1 site in Taiwan.
Trial summary
The objective of study is to assess the repeatability and agreement of the retina and cornea measurement by Vision-700 in comparison with those by 3D OCT-1. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Subject, Glaucoma, Retinal Disease
- What is being tested?
- Vision-700
- Type of treatment
- Medical device
- How many people
- 159 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2022to 31 Jul 2023
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects, Glaucoma subjects, Retinal diseasse subjects, Cornea condition subjects
Who may be able to join
- Subject 22 years old or older on the date of informed consent; Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
- Normal Group:
- (1)Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable). (2)IOP ≤ 21 mmHg bilaterally; BCVA 20/40 or better bilaterally. (3) No history of corneal, glaucoma, or retinal diseases. (4)No history of ocular surgeries, including laser refractive surgery, cataract surgery, glaucoma surgery and retinal surgery. (5)Subjects without 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.
- Glaucoma Group:
- With a current BCVA of 20/40 or better in the glaucoma study eyes. (2) History of visual field defects within the previous six months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage. (3) Subjects who have been diagnosed with glaucoma in the glaucoma study eyes based on the presence of visual field defects, regardless of the optic nerve head and RNFL appearance. (4) Subjects without retinal disease or cornea condition in the glaucoma study eyes, as determined by self-report and/or investigator assessment at the study visit.
- Retinal Disease Group:
Show all 9Show fewer
- (1)Subjects with a current BCVA of 20/400 or better in the retinal disease study eye(s) at the study visit. (2)Subjects diagnosed with retinal pathology including but not limited to any one of following criteria: a. Non Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit structural lesions in the study eye; b. Neovascular Macular Degeneration (wet AMD), Diabetic Retinopathy, Retinal Artery Occlusion, Retinal Vein Occlusion or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit vascular and/or ischemic lesions in the study eye. (3) Subjects without glaucoma or cornea condition in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit.
- Cornea Condition Group:
- History of refractive surgery, contact lens (wear contact lens more than 6 months), dry eye or keratoconus.
Who cannot join
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects with a history of leukemia, dementia or multiple sclerosis.
- Subjects with history of hydroxychloroquine or chloroquine use
- Subjects with photosensitivity
- Subject having Photodynamic therapy (PDT) within 6 months
- Subjects taking photosensitivity drug currently
- Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of an Automated Optical Coherence Tomography and Camera : Effectiveness o
The objective of study is to assess the repeatability and agreement of the retina and cornea measurement by Vision-700 in comparison with those by 3D OCT-1.
Read the detailed description
The first objective of study is to assess the repeatability and agreement of the retina and cornea measurement by Vision-700 in comparison with those by 3D OCT-1, and Cornea Measurements by RTVue XR + CAM. The second objective is to compare the agreement of fundus photography quality between Vision-700 with 3D OCT-1.
- Conditions
- Normal Subject, Glaucoma, Retinal Disease, Cornea
- Being tested
- Vision-700
- Medical subject headings
- Glaucoma, Retinal Diseases, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision-700Device
Also called 3D OCT-1 Maestro
OCT machines used for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Normal Group: | (1)Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable). (2)IOP ≤ 21 mmHg bilaterally; BCVA 20/40 or better bilaterally. (3) No history of corneal, glaucoma, or retinal diseases. (4)No history of ocular surgeries, including laser refractive surgery, cataract surgery, glaucoma surgery and retinal surgery. (5)Subjects without 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. Receives: Device: Vision-700 | |
| Glaucoma Group | (1) With a current BCVA of 20/40 or better in the glaucoma study eyes. (2) History of visual field defects within the previous six months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage. (3) Subjects who have been diagnosed with glaucoma in the glaucoma study eyes based on the presence of visual field defects, regardless of the optic nerve head and RNFL appearance. (4) Subjects without retinal disease or cornea condition in the glaucoma study eyes, as determined by self-report and/or investigator assessment at the study visit. Receives: Device: Vision-700 | |
| Retinal Disease Group | (1)Subjects with a current BCVA of 20/400 or better in the retinal disease study eye(s) at the study visit. (2)Subjects diagnosed with retinal pathology including but not limited to any one of following criteria: a. Non Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit structural lesions in the study eye; b. Neovascular Macular Degeneration (wet AMD), Diabetic Retinopathy, Retinal Artery Occlusion, Retinal Vein Occlusion or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit vascular and/or ischemic lesions in the study eye. (3) Subjects without glaucoma or cornea condition in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit. Receives: Device: Vision-700 | |
| Cornea Condition Group | History of refractive surgery, contact lens (wear contact lens more than 6 months), dry eye or keratoconus. Receives: Device: Vision-700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Precision of Vision-700 in Retinal and Cornea Measurement
The Precision included the repeatability and reproducibility.
Measured: 2022/9/1
The Precision of 3D OCT-1 in Retinal and Cornea Measurements
The Precision included the repeatability and reproducibility.
Measured: 2022/9/1
The Agreement of Vision-700 and 3D OCT-1 in Retinal and Cornea Measurements
the agreement study
Measured: 2022/9/1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Sep 2022
- Primary completion1 Sep 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal SubjectStudies 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
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crystalvue Medical Coporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- I-Chia Liang, Principal investigator, Tri-Services General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496763
- Sponsor's protocol ID
- Effectiveness of Vision-700
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Automated Optical Coherence Tomography and Camera : Effectiveness o
- ClinicalTrials.gov ID
- NCT06496763
- Acronym / sponsor ID
- Effectiveness of Vision-700
- Conditions
- Normal Subject, Glaucoma, Retinal Disease, Cornea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Crystalvue Medical CoporationIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 11 Jul 2024 (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 objective of study is to assess the repeatability and agreement of the retina and cornea measurement by Vision-700 in comparison with those by 3D OCT-1.
Detailed description
The first objective of study is to assess the repeatability and agreement of the retina and cornea measurement by Vision-700 in comparison with those by 3D OCT-1, and Cornea Measurements by RTVue XR + CAM. The second objective is to compare the agreement of fundus photography quality between Vision-700 with 3D OCT-1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Group: | – | Device: Vision-700(1)Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable). (2)IOP ≤ 21 mmHg bilaterally; BCVA 20/40 or better bilaterally. (3) No history of corneal, glaucoma, or retinal diseases. (4)No history of ocular surgeries, including laser refractive surgery, cataract surgery, glaucoma surgery and retinal surgery. (5)Subjects without 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. |
| Glaucoma Group | – | Device: Vision-700(1) With a current BCVA of 20/40 or better in the glaucoma study eyes. (2) History of visual field defects within the previous six months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage. (3) Subjects who have been diagnosed with glaucoma in the glaucoma study eyes based on the presence of visual field defects, regardless of the optic nerve head and RNFL appearance. (4) Subjects without retinal disease or cornea condition in the glaucoma study eyes, as determined by self-report and/or investigator assessment at the study visit. |
| Retinal Disease Group | – | Device: Vision-700(1)Subjects with a current BCVA of 20/400 or better in the retinal disease study eye(s) at the study visit. (2)Subjects diagnosed with retinal pathology including but not limited to any one of following criteria: a. Non Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit structural lesions in the study eye; b. Neovascular Macular Degeneration (wet AMD), Diabetic Retinopathy, Retinal Artery Occlusion, Retinal Vein Occlusion or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit vascular and/or ischemic lesions in the study eye. (3) Subjects without glaucoma or cornea condition in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit. |
| Cornea Condition Group | – | Device: Vision-700History of refractive surgery, contact lens (wear contact lens more than 6 months), dry eye or keratoconus. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects, Glaucoma subjects, Retinal diseasse subjects, Cornea condition subjects
Key inclusion criteria (9 listed)
- Subject 22 years old or older on the date of informed consent; Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
- (1)Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable). (2)IOP ≤ 21 mmHg bilaterally; BCVA 20/40 or better bilaterally. (3) No history of corneal, glaucoma, or retinal diseases. (4)No history of ocular surgeries, including laser refractive surgery, cataract surgery, glaucoma surgery and retinal surgery. (5)Subjects without 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.
- With a current BCVA of 20/40 or better in the glaucoma study eyes. (2) History of visual field defects within the previous six months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage. (3) Subjects who have been diagnosed with glaucoma in the glaucoma study eyes based on the presence of visual field defects, regardless of the optic nerve head and RNFL appearance. (4) Subjects without retinal disease or cornea condition in the glaucoma study eyes, as determined by self-report and/or investigator assessment at the study visit.
- (1)Subjects with a current BCVA of 20/400 or better in the retinal disease study eye(s) at the study visit. (2)Subjects diagnosed with retinal pathology including but not limited to any one of following criteria: a. Non Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit structural lesions in the study eye; b. Neovascular Macular Degeneration (wet AMD), Diabetic Retinopathy, Retinal Artery Occlusion, Retinal Vein Occlusion or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit vascular and/or ischemic lesions in the study eye. (3) Subjects without glaucoma or cornea condition in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit.
- History of refractive surgery, contact lens (wear contact lens more than 6 months), dry eye or keratoconus.
Key exclusion criteria (8 listed)
- Subjects unable to tolerate ophthalmic imaging;
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
- Subjects with a history of leukemia, dementia or multiple sclerosis.
- Subjects with history of hydroxychloroquine or chloroquine use
- Subjects with photosensitivity
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 |
|---|---|---|
| Vision-700Also: 3D OCT-1 MaestroOCT machines used for diagnostic purposes | Device | Cornea Condition Group, Glaucoma Group, Normal Group:, Retinal Disease Group |
Primary outcome
The Precision of Vision-700 in Retinal and Cornea Measurement
Time frame: 2022/9/1
The Precision included the repeatability and reproducibility.
The Precision of 3D OCT-1 in Retinal and Cornea Measurements
Time frame: 2022/9/1
The Precision included the repeatability and reproducibility.
The Agreement of Vision-700 and 3D OCT-1 in Retinal and Cornea Measurements
Time frame: 2022/9/1
the agreement study
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 11 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Normal Subject
Recruiting
Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects
Breast Carcinoma, Healthy Subject
Not yet recruitingObservational study
Public Attitudes Towards Traditional Medicine in Dermatological Care Within Blantyre, Malawi: Insights From Subject Matter Experts
Skin Conditions and Traditional Medicine
Recruiting
Within-Subject Comparison of Adipose Tissue Viability Following Liposuction
Liposuction
Recruiting
Efficacy of Topical Niacinamide Riboside on the Signs of Facial Skin Aging
Skin Aging on Face, Skin Care Dermocosmetics
RecruitingPhase 1
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
Oncology, MEK Mutation
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.
I-Chia Liang principal investigator
Tri-Services General Hospital
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 Normal Subject and Glaucoma, run by Crystalvue Medical Coporation at 1 site in Taiwan.
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 9 inclusion and 8 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 11 Jul 2024. 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 Taiwan. 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?
The Precision of Vision-700 in Retinal and Cornea Measurement (time frame: 2022/9/1). The study lists 3 primary outcomes in all. 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 11 Jul 2024.