Status:
COMPLETED
Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
Lead Sponsor:
Robotrak Technologies Co., Ltd.
Conditions:
Retinal Disease
Healthy
Eligibility:
All Genders
18-65 years
Brief 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 exami...
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 al...
Eligibility Criteria
Inclusion
- Inclusion criteria：
- Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;
- Can fully cooperate with instructions to complete the inspection
- 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：
- Patients with high intraocular pressure (\>21mmHg) or other reasons who cannot undergo mydriasis;
- For those with a spherical lens degree exceeding 5D or a cylindrical lens degree exceeding ± 2D,
- those with ptosis or other conditions that cannot fully expose the pupil area
- Aphthalmic or intraocular lens eyes
- Those who have received photodynamic therapy within 48 hours;
- 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;
Exclusion
Key Trial Info
Start Date :
July 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 16 2023
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT06173414
Start Date
July 5 2023
End Date
November 16 2023
Last Update
December 15 2023
Active Locations (1)
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1
Robotrak Technologies Co., Ltd.
Nanjing, China