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NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients
Primary objective:
To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients.
Secondary objectives:
- To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients.
- To evaluate patient experience when self-operating the Notal-OCT V2.5.
| Condition or disease | Intervention/treatment |
|---|---|
| AMD - Age-Related Macular Degeneration Diabetic Macular Edema | Device: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5) |
To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DME patients. OCT images from the central 10 degrees of the macula in DME patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
Patients will complete a questionnaire regarding the usability of the NOTAL-OCT v.2.5 device
| Study Type : | Observational |
| Actual Enrollment : | 287 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Comparison Between Retinal Images Captured by NOTAL-OCT V2.5 and Zeiss Cirrus / Heidelberg Spectralis SD OCT - Study Protocol |
| Actual Study Start Date : | October 20, 2018 |
| Actual Primary Completion Date : | July 11, 2019 |
| Actual Study Completion Date : | October 4, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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NOTAL OCT v.2.5 and Commercial OCT on AMD Patients
OCT Images will be obtained in the central 10 degrees of the macula in AMD patients using the NOTAL OCT v.2.5 device and a Commercial device (Zeiss Cirrus/Heidelberg SPECTRALIS).
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Device: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)
OCT SCAN
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- Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients [ Time Frame: less than an hour ]To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
- Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in DR (Diabetic Retinopathy) patients [ Time Frame: less then an hour ]To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DR patients. OCT images from the central 10 degrees of the macula in DR patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
- Patient experience using the NOTAL-OCT v.2.5 device [ Time Frame: less than an hour ]Patients will complete a questionnaire with 13 statements or questions regarding the usability of the NOTAL-OCT v.2.5 device. For the first 10 statements, patients are asked to specify a level of agreement to the statement. The scale is named "Level of Agreement" and ranges from 1 = strongly agree, to 5 = strongly disagree. A patient's indicating a value of 1 is considered to be a better outcome. The remaining 3 questions are free-form.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Ability and willingness to give informed consent (IC)
- 18 years of age or older
- Diagnosis of AMD (age-related macular degeneration) and/or DME (diabetic macular edema) in the study eye as confirmed by the investigator and recorded in the patient's clinical record
- Ability to undergo OCT (optical coherence tomography) testing
- Visual acuity of 20/400 Snellen (6/120) or better in the study eye
Exclusion Criteria:
- Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.
| United States, Maryland | |
| Elman Retina Group, PA | |
| Baltimore, Maryland, United States, 21237 | |
| Principal Investigator: | Michael Elman | Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237 |
| Tracking Information | |||||
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| First Submitted Date | October 23, 2018 | ||||
| First Posted Date | May 31, 2019 | ||||
| Last Update Posted Date | November 12, 2020 | ||||
| Actual Study Start Date | October 20, 2018 | ||||
| Actual Primary Completion Date | July 11, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients [ Time Frame: less than an hour ] To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients | ||||
| Official Title | Comparison Between Retinal Images Captured by NOTAL-OCT V2.5 and Zeiss Cirrus / Heidelberg Spectralis SD OCT - Study Protocol | ||||
| Brief Summary |
Primary objective: To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients. Secondary objectives:
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| Detailed Description |
To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images. To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DME patients. OCT images from the central 10 degrees of the macula in DME patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images. Patients will complete a questionnaire regarding the usability of the NOTAL-OCT v.2.5 device |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | AMD and DME patients | ||||
| Condition |
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| Intervention | Device: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)
OCT SCAN
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| Study Groups/Cohorts | NOTAL OCT v.2.5 and Commercial OCT on AMD Patients
OCT Images will be obtained in the central 10 degrees of the macula in AMD patients using the NOTAL OCT v.2.5 device and a Commercial device (Zeiss Cirrus/Heidelberg SPECTRALIS).
Intervention: Device: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
287 | ||||
| Original Estimated Enrollment |
80 | ||||
| Actual Study Completion Date | October 4, 2019 | ||||
| Actual Primary Completion Date | July 11, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: - Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03969303 | ||||
| Other Study ID Numbers | C2018.008 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Notal Vision Inc. ( Notal Vision Ltd. ) | ||||
| Study Sponsor | Notal Vision Ltd. | ||||
| Collaborators | Elman Retina Group | ||||
| Investigators |
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| PRS Account | Notal Vision Inc. | ||||
| Verification Date | October 2020 | ||||
