Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607369
Status:
UNKNOWN
Last Update Posted:
2022-02-01
First Post:
2020-10-07
Brief Title:
Implementation of the NEDS EyeCTester App
Sponsor:
Neuro-Eye Diagnostic Systems LLC
Organization:
Neuro-Eye Diagnostic Systems LLC
Study Overview
Official Title:
Implementation of the NEDS EyeCTester App and NEDS Server Analysis Software Into the Homes of Patients With Neuro-ophthalmic Retinal and Other Diseases to Enhance Early Detection of Active Eye Disease
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ENROLLING_BY_INVITATION
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:
Group 4a and 4b was an FDA trial that showed that patients who have an Amsler grid abnormality on paper have a similar abnormality on the app
Group 7a and 7b was an FDA trial that showed that normal patients do not have false positives on the Amsler app as well as on the Amsler paper version Further Vision on the app is slightly better than vision on the standard Sloan near card using a formula vision is 710th of a line better on the app
Group 7a and 7b was an FDA trial that showed that normal patients do not have false positives on the Amsler app as well as on the Amsler paper version Further Vision on the app is slightly better than vision on the standard Sloan near card using a formula vision is 710th of a line better on the app
Detailed Description:
Detailed Description of 4A and 4B A series of patients with central visual defects were identified and their names were given to the unblinded clinical coordinator The clinical coordinator contacted the patients described the study arranged the appointments to come to the clinic one-at-a-time for a dedicated visit to participate in the study Each patient experienced the same study process for their visit
1 Met with the unblinded Clinical Coordinator who had the patient sign the informed consent after detailed explanation
2 Had the Clinical Coordinator put a number tag on the patient and this was the number that the blinded participants of the study were to use for these subjects Additionally random numbers were used on the test forms
3 Patients met with blinded test trainer where the patient was provided standardized instruction for use of Amsler grid on-paper test the Amsler grid on EyeQTester device visual acuity and color sensitivity on paper and on the device The instruction was enhanced between Cohort 1 and Cohort 2 as approved by the IRB for the different instruction protocol see below discussion Also patients were given a test which they must pass in order to enter the trial
4 Patients then met with the blinded test administrator where the patient took the tests with no coaching The test admin confirmed that the environmental parameters were similar across all patients over the course of the study
5 The patient completed test and re-test sequences
6 All test results with assigned random numbers were reported by the test administrator to the Clinical Coordinator who provided batches of blinded results to the Data Coordinator
The investigators knew from prior clinic experience that the patients required a new and more detailed educational experience than was standard in order to have more reliable results for both the paper and app Amsler Grid test in order to measure the central visual fields The investigators focused on carefully training the patient through both written material and a video where the educational administrator was there to review this with the patient The education focused on
1 What are defects and how to identify and report them
2 How to draw the above defects with attention to distance from the fixation point size of the defect as well as its density
Training enhancement was prompted midway through the trial when the unblinded sponsor and clinical coordinator reviewed patient test results Initial conclusion was that the patients exhibited defect identification on both paper and app that could possibly be enhanced by improving the educational protocol An updated educational protocol was provided which the sponsor discussed with the educational team which was implemented to test if this updated patient education would result in more reliable results It was decided to utilize updated educational approach for all patients on both paper and the app Additionally the investigators added a stylus for the app replacing the patients finger in order to more closely simulate a pen which is utilized for the paper This updated approach was submitted and approved by the IRB
As a result of the above a decision was made to have two cohorts in the study the early education cohort 1 and the later education cohort 2 Patients in cohort 1 were trained on the device to draw a defect on the screen with the tip of their finger but on paper to use a pen Patients in cohort 2 were trained on the device to draw a defect on the screen with a stylus and on paper with a pen The result in Cohort 2 was that consistency of the patients test results were better for both test and re-test for both the Amsler grid on-paper and the EyeCTester device
The statistical analysis in this report shows the overall results and also the improved results in Cohort 2 that likely is attributed to these educational enhancement and stylus additions
The full protocol for the trial including the training is available in the WIRB trial documentation
Sample Size Calculation by our statistician was verified to be the sample size used was statistically acceptable
Summary Amsler app and paper version were equivalent and best when using a stylus on the app
Detailed Description of 7A and 7 B A series of patients 22 and over without any vision problems being examined similar to the above see WIRB description with a different education protocol consisting of in-home video on the app telemedical connection by COA to confirm teaching was understood and if not reteach
The statistical analysis in this report shows the overall results showed that the vision testing standard and app were similar with better vision tested on the app by a formula that approximates 710 of a line better
The statistical analysis in this report shows the overall results showed that the color testing standard and app were similar
The statistical analysis in this report shows the overall results showed that the Amsler grid testing via standard near vision tests and app were exactly the same with neither having false positives
The full protocol for the trial including the training is available in the WIRB trial documentation
Sample Size Calculation by our statistician was verified to be the sample size used was statistically acceptable
1 Met with the unblinded Clinical Coordinator who had the patient sign the informed consent after detailed explanation
2 Had the Clinical Coordinator put a number tag on the patient and this was the number that the blinded participants of the study were to use for these subjects Additionally random numbers were used on the test forms
3 Patients met with blinded test trainer where the patient was provided standardized instruction for use of Amsler grid on-paper test the Amsler grid on EyeQTester device visual acuity and color sensitivity on paper and on the device The instruction was enhanced between Cohort 1 and Cohort 2 as approved by the IRB for the different instruction protocol see below discussion Also patients were given a test which they must pass in order to enter the trial
4 Patients then met with the blinded test administrator where the patient took the tests with no coaching The test admin confirmed that the environmental parameters were similar across all patients over the course of the study
5 The patient completed test and re-test sequences
6 All test results with assigned random numbers were reported by the test administrator to the Clinical Coordinator who provided batches of blinded results to the Data Coordinator
The investigators knew from prior clinic experience that the patients required a new and more detailed educational experience than was standard in order to have more reliable results for both the paper and app Amsler Grid test in order to measure the central visual fields The investigators focused on carefully training the patient through both written material and a video where the educational administrator was there to review this with the patient The education focused on
1 What are defects and how to identify and report them
2 How to draw the above defects with attention to distance from the fixation point size of the defect as well as its density
Training enhancement was prompted midway through the trial when the unblinded sponsor and clinical coordinator reviewed patient test results Initial conclusion was that the patients exhibited defect identification on both paper and app that could possibly be enhanced by improving the educational protocol An updated educational protocol was provided which the sponsor discussed with the educational team which was implemented to test if this updated patient education would result in more reliable results It was decided to utilize updated educational approach for all patients on both paper and the app Additionally the investigators added a stylus for the app replacing the patients finger in order to more closely simulate a pen which is utilized for the paper This updated approach was submitted and approved by the IRB
As a result of the above a decision was made to have two cohorts in the study the early education cohort 1 and the later education cohort 2 Patients in cohort 1 were trained on the device to draw a defect on the screen with the tip of their finger but on paper to use a pen Patients in cohort 2 were trained on the device to draw a defect on the screen with a stylus and on paper with a pen The result in Cohort 2 was that consistency of the patients test results were better for both test and re-test for both the Amsler grid on-paper and the EyeCTester device
The statistical analysis in this report shows the overall results and also the improved results in Cohort 2 that likely is attributed to these educational enhancement and stylus additions
The full protocol for the trial including the training is available in the WIRB trial documentation
Sample Size Calculation by our statistician was verified to be the sample size used was statistically acceptable
Summary Amsler app and paper version were equivalent and best when using a stylus on the app
Detailed Description of 7A and 7 B A series of patients 22 and over without any vision problems being examined similar to the above see WIRB description with a different education protocol consisting of in-home video on the app telemedical connection by COA to confirm teaching was understood and if not reteach
The statistical analysis in this report shows the overall results showed that the vision testing standard and app were similar with better vision tested on the app by a formula that approximates 710 of a line better
The statistical analysis in this report shows the overall results showed that the color testing standard and app were similar
The statistical analysis in this report shows the overall results showed that the Amsler grid testing via standard near vision tests and app were exactly the same with neither having false positives
The full protocol for the trial including the training is available in the WIRB trial documentation
Sample Size Calculation by our statistician was verified to be the sample size used was statistically acceptable
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?:
False
Is an FDA AA801 Violation?:
None