Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173414
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2023-11-22
Brief Title:
Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
Sponsor:
Robotrak Technologies Co Ltd
Organization:
Robotrak Technologies Co Ltd
Study Overview
Official Title:
Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-12
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:
This prospective multicenter single-group target-value clinical trial was designed to evaluate the efficacy and safety of an Adaptive Optics ScanningLaser OphthalmoscopeAOSLO for ophthalmic examination
Detailed Description:
objective This study aims to collect AOSLO retinal images from human population to assess the imaging quality and quantitative measurement consistency of AOSLO devices manufactured by Robotrak and also monitor any possible side effects
study population randomly invited 194 volunteers who meets inclusion criteria
design the study is an observational protocol that participants will be imaged with Robotrak AOSLO systems to get cellular level images of photoreceptors and blood vessels in foveal area Automatics analysis of cellblood vessel morphology parameters will be calculated for consistency evaluation In general participants will undergo a complete ophthalmic examination including assessments of visual acuity intraocular pressure slit lamp examination ocular biometry OCT fundus imaging multi-focal ERG and OCT scan to assess potential side effects of AOSLO imaging
outcome measures the primary efficacy outcome measure of this study are multi expert grading of the image quality collected
the secondary efficacy outcome measure are quantitative assessment of the morphological parameters generated from the captured images and device operator ratings
the safety measures are side effect signs from ophthalmic examinations beforeafter AOSLO imaging
study population randomly invited 194 volunteers who meets inclusion criteria
design the study is an observational protocol that participants will be imaged with Robotrak AOSLO systems to get cellular level images of photoreceptors and blood vessels in foveal area Automatics analysis of cellblood vessel morphology parameters will be calculated for consistency evaluation In general participants will undergo a complete ophthalmic examination including assessments of visual acuity intraocular pressure slit lamp examination ocular biometry OCT fundus imaging multi-focal ERG and OCT scan to assess potential side effects of AOSLO imaging
outcome measures the primary efficacy outcome measure of this study are multi expert grading of the image quality collected
the secondary efficacy outcome measure are quantitative assessment of the morphological parameters generated from the captured images and device operator ratings
the safety measures are side effect signs from ophthalmic examinations beforeafter AOSLO imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None