Loading clinical trials...

COMPLETED

Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial

NCT06173414•Robotrak Technologies Co., Ltd.

Summary

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.

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 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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;
•2. Can fully cooperate with instructions to complete the inspection
•3. The subject (or their designated agent) voluntarily participates and signs an informed consent form. Note: At least 63 subjects with no obvious eye abnormalities were enrolled (determined by the researcher through ophthalmic examination)

Exclusion Criteria

•1. Patients with high intraocular pressure (\>21mmHg) or other reasons who cannot undergo mydriasis;
•2. For those with a spherical lens degree exceeding 5D or a cylindrical lens degree exceeding ± 2D,
•3. those with ptosis or other conditions that cannot fully expose the pupil area
•4. Aphthalmic or intraocular lens eyes
•5. Those who have received photodynamic therapy within 48 hours;
•6. Individuals with a history of photosensitivity or taking medication that may cause photosensitive side effects 7）Those who have obvious skin lesions on the lower jaw or forehead and are unable to contact the lower jaw or forehead support
•8\) Individuals with epidemic keratoconjunctivitis or in the active phase of other infectious diseases 9) Those whose refractive medium is turbid and unable to obtain satisfactory images; 10) Poor fixation or inability to cooperate with the examination due to other reasons; 11) Pregnant or lactating women;

Locations (1)

Robotrak Technologies Co., Ltd.

Nanjing, China

Key Dates

Start Date

July 5, 2023

Primary Completion Date

October 31, 2023

Completion Date

November 16, 2023

Last Updated

December 15, 2023

Enrollment

194

ACTUAL participants

Conditions

Retinal DiseaseHealthy

Interventions

No intervention measures

OTHER

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

NCT06290258

Autism Spectrum DisorderGastrointestinal Diseases+1 more

View study

RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial

Inclusion Criteria

Exclusion Criteria

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Collection of Data and Samples From Healthy Donors for Use in Translational Research

A New Portable Device for Non-invasive Ventilatory Support

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases