Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745116
Status:
RECRUITING
Last Update Posted:
2023-02-27
First Post:
2023-01-06
Brief Title:
Evaluation of Repeated In-Clinic Self-Imaging by DME Patients Using the Notal Vision Home OCT
Sponsor:
Notal Vision Inc
Organization:
Notal Vision Inc
Study Overview
Official Title:
Evaluation of Repeated In-Clinic Self-Imaging by DME Patients Using the Notal Vision
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of Repeated In-Clinic Self-Imaging by DME Patients Using the Notal Vision Home OCT The purpose of this study is to collect data on the NVHO device at up to three sites
Detailed Description:
7 Study Procedures and Office Visit Schedule Informed Consent Voluntary informed consent will be obtained from every subject prior to the initiation of any screening or other study related procedures The Investigator must have a defined process for obtaining informed consent Specifically the Investigator or designee will explain the clinical study to each potential patient and the patient must indicate voluntary consent by signing and dating of the approved informed consent form The patient must be provided an opportunity to ask questions to the Investigator and if required by local regulation other qualified personnel
Description of Study Procedures and Visits 721 Office Visit NOTE Any planned treatment for DME at the day of the study should be administered after completion of all study-related scans
At the enrollment Office Visit the exams will be conducted in the following order
1 Patient will be informed concerning the study and sign the Informed Consent Form ICF prior to conduct of any study procedures 2 Following signing the ICF subjects will be assigned a Subject ID by a designated staff at the clinical site 3 The following data will be collected for each study subject
1 Date of birth
2 Gender
3 Number and type of Anti-VEGF injections and last injection date 3 Refraction correction 4 Snellen BCVA on both eyes on the day of the visit 5 Eligible eyes of the subject will be scanned non-dilated with a Zeiss Cirrus or Spectralis OCT device with one 1 acceptable volume scan of each eye being obtained out of up to 3 attempts
Scanning pattern to be used
Zeiss Cirrus Macular cube 6X6mm 128 B-scans per volume scan Or Spectralis Dense preset scan size 20x20 section images 49 ART Mean 16 scan angle cSLO image 30 image resolution High speed centered on the fovea
RD DOCUMENTS C2022001 Subject Single In-Clinic Encounter with the Notal Vision Home OCT Page 11 OF 18 Version 3 FOR CONFIDENTIAL USE ONLY October 2022 6 Eyes of the subject that meet all screening criteria will be enrolled If both eyes of the subjects meet all screening criteria both eyes will be enrolled NOTE Approximately 90 of the enrolled subjects should have at least one eye with DME at the time of enrollment 7 The following data will be collected for the study eyes
a Qualifying diagnosis for the study eye from the subjects medical record b From the subjects medical record the presence of other ophthalmic conditions including but not limited to i Cataract ii Glaucoma iii Dry Eye iv Other macula findings eg epi retinal membrane macular hole vitreo-macular traction VMT Following confirmation of subject eligibility subject will be placed in a room with the NVHO device which has been set up by a technician
1 The technician will register the subject using the touchscreen of the NVHO device
2 The subject will perform a self-tutorial The training flow begins with demonstration clips followed by a practice session The training flow will be followed by a self-scan that the system uses as a calibration session
3 Following completion of the training the clinic technician shall set the device for selfscanning flow
4 Following the training the subject must complete a unsupervised successful calibration scan on each study eyes The technician will check the status of the calibration scan successfailure using a dedicated screen on the device presented at the end of each scanning session Each study eye has up to 3 attempts to complete a successful calibration scan
5 If an eye went through a successful calibration scan a Success message in green letters will be presented on the dedicated screen at the end of the session and this eye will be ready to start the scanning phase
6 In case of failure in all 3 calibration attempts an error message 3 successive calibrations failed will be presented in red letters on the dedicated screen In that case this eye should be excluded from the study and the technician should prevent the patient from re-scanning it RD DOCUMENTS C2022001 Subject Single In-Clinic Encounter with the Notal Vision Home OCT Page 12 OF 18 Version 3 FOR CONFIDENTIAL USE ONLY October 2022
7 Scanning phase - the subject will perform four 4 unsupervised self-scans on each study eye with a rest period of 2 minutes between self-scans
5 AEs if applicable will be collected 6 Exit subject from the study 7 Self-scan data will be backed up on the NVHO device 8 Study visit data will be registered into the sponsor-provided CRF and sent to Notal The Zeiss Cirrus or Spectralis OCT images will undergo anonymization process using identical CRF name and number of the subject and will be sent to Notal Discontinued Subjects Discontinued subjects are those who withdraw or are withdrawn from the study after being successfully consented into the study Subjects may discontinue from the study at any time for any reason Subjects may be discontinued from the study at any time if in the opinion of the Investigator their continued participation poses a risk to their health Discontinued subjects will not be replaced ie their subject number will not be reassigned or reused An Exit form must be completed for all subjects Clinical Study Initiation and Termination Before the study can commence the Sponsor or its designee must ensure that all relevant study documents are available and that the Site Initiation has been performed Only then can arrangements be made for start of recruitment If the clinical study is terminated or suspended the Sponsor will inform the Investigator and the regulatory authorities of the terminationsuspension and the reasons for the terminationsuspension
The Investigator should promptly notify the IECIRB Independent Ethics CommitteeInstitutional Review Board of the terminationsuspension and of the reasons The Sponsor reserves the right to close the investigational site or terminate the study in its entirely at any time for reasonable cause
Reasons for the closure of an investigational site or termination of a study may include
1 Successful completion of the study
2 Study enrollment goals are met
3 Investigator fails to comply with the protocol or GCP guidelines
4 Safety concerns
5 Sufficient data suggesting lack of efficacy
6 Inadequate recruitment of patients by the Investigator The investigator also may terminate the study at hisher site for reasonable cause If the Sponsor terminates the study for safety reasons it will immediately notify the Investigator by telephone and subsequently will provide written confirmation and instructions for study termination
Description of Study Procedures and Visits 721 Office Visit NOTE Any planned treatment for DME at the day of the study should be administered after completion of all study-related scans
At the enrollment Office Visit the exams will be conducted in the following order
1 Patient will be informed concerning the study and sign the Informed Consent Form ICF prior to conduct of any study procedures 2 Following signing the ICF subjects will be assigned a Subject ID by a designated staff at the clinical site 3 The following data will be collected for each study subject
1 Date of birth
2 Gender
3 Number and type of Anti-VEGF injections and last injection date 3 Refraction correction 4 Snellen BCVA on both eyes on the day of the visit 5 Eligible eyes of the subject will be scanned non-dilated with a Zeiss Cirrus or Spectralis OCT device with one 1 acceptable volume scan of each eye being obtained out of up to 3 attempts
Scanning pattern to be used
Zeiss Cirrus Macular cube 6X6mm 128 B-scans per volume scan Or Spectralis Dense preset scan size 20x20 section images 49 ART Mean 16 scan angle cSLO image 30 image resolution High speed centered on the fovea
RD DOCUMENTS C2022001 Subject Single In-Clinic Encounter with the Notal Vision Home OCT Page 11 OF 18 Version 3 FOR CONFIDENTIAL USE ONLY October 2022 6 Eyes of the subject that meet all screening criteria will be enrolled If both eyes of the subjects meet all screening criteria both eyes will be enrolled NOTE Approximately 90 of the enrolled subjects should have at least one eye with DME at the time of enrollment 7 The following data will be collected for the study eyes
a Qualifying diagnosis for the study eye from the subjects medical record b From the subjects medical record the presence of other ophthalmic conditions including but not limited to i Cataract ii Glaucoma iii Dry Eye iv Other macula findings eg epi retinal membrane macular hole vitreo-macular traction VMT Following confirmation of subject eligibility subject will be placed in a room with the NVHO device which has been set up by a technician
1 The technician will register the subject using the touchscreen of the NVHO device
2 The subject will perform a self-tutorial The training flow begins with demonstration clips followed by a practice session The training flow will be followed by a self-scan that the system uses as a calibration session
3 Following completion of the training the clinic technician shall set the device for selfscanning flow
4 Following the training the subject must complete a unsupervised successful calibration scan on each study eyes The technician will check the status of the calibration scan successfailure using a dedicated screen on the device presented at the end of each scanning session Each study eye has up to 3 attempts to complete a successful calibration scan
5 If an eye went through a successful calibration scan a Success message in green letters will be presented on the dedicated screen at the end of the session and this eye will be ready to start the scanning phase
6 In case of failure in all 3 calibration attempts an error message 3 successive calibrations failed will be presented in red letters on the dedicated screen In that case this eye should be excluded from the study and the technician should prevent the patient from re-scanning it RD DOCUMENTS C2022001 Subject Single In-Clinic Encounter with the Notal Vision Home OCT Page 12 OF 18 Version 3 FOR CONFIDENTIAL USE ONLY October 2022
7 Scanning phase - the subject will perform four 4 unsupervised self-scans on each study eye with a rest period of 2 minutes between self-scans
5 AEs if applicable will be collected 6 Exit subject from the study 7 Self-scan data will be backed up on the NVHO device 8 Study visit data will be registered into the sponsor-provided CRF and sent to Notal The Zeiss Cirrus or Spectralis OCT images will undergo anonymization process using identical CRF name and number of the subject and will be sent to Notal Discontinued Subjects Discontinued subjects are those who withdraw or are withdrawn from the study after being successfully consented into the study Subjects may discontinue from the study at any time for any reason Subjects may be discontinued from the study at any time if in the opinion of the Investigator their continued participation poses a risk to their health Discontinued subjects will not be replaced ie their subject number will not be reassigned or reused An Exit form must be completed for all subjects Clinical Study Initiation and Termination Before the study can commence the Sponsor or its designee must ensure that all relevant study documents are available and that the Site Initiation has been performed Only then can arrangements be made for start of recruitment If the clinical study is terminated or suspended the Sponsor will inform the Investigator and the regulatory authorities of the terminationsuspension and the reasons for the terminationsuspension
The Investigator should promptly notify the IECIRB Independent Ethics CommitteeInstitutional Review Board of the terminationsuspension and of the reasons The Sponsor reserves the right to close the investigational site or terminate the study in its entirely at any time for reasonable cause
Reasons for the closure of an investigational site or termination of a study may include
1 Successful completion of the study
2 Study enrollment goals are met
3 Investigator fails to comply with the protocol or GCP guidelines
4 Safety concerns
5 Sufficient data suggesting lack of efficacy
6 Inadequate recruitment of patients by the Investigator The investigator also may terminate the study at hisher site for reasonable cause If the Sponsor terminates the study for safety reasons it will immediately notify the Investigator by telephone and subsequently will provide written confirmation and instructions for study termination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None