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Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial

NCT ID: NCT06173414

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-05

Study Completion Date

2023-11-16

Brief Summary

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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

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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

Conditions

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Retinal Disease Healthy

Keywords

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healthy patients eye disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention measures

No intervention measures

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robotrak Technologies Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qian Liu, O.D.

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial Eye Hospital

Locations

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Robotrak Technologies Co., Ltd.

Nanjing, , China

Site Status

Countries

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China

Other Identifiers

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RT-MONA-2023-01

Identifier Type: -

Identifier Source: org_study_id