Healthy Clinical Trial
Official title:
Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
This prospective, multicenter, single-group, target-value clinical trial was designed to evaluate the efficacy and safety of an Adaptive Optics ScanningLaser Ophthalmoscope(AOSLO) for ophthalmic examination.
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 cell/blood 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 before&after AOSLO imaging ;
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