Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial

NCT06173414 | Completed

• 1 other identifier: RT-MONA-2023-01
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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 examination.

Conditions

Retinal Disease; Healthy

Keywords

healthy patients; eye disease

Outcome Measures

Primary Outcomes (1)

• Image quality excellence rate

  Divide the collected images into 25 small squares based on a 5X5 square grid; Divide each small square into "clear" and "under clear" based on whether the mosaic structure of photosensitive cells is clear and visible. Divide the entire 2.4 ° X2.4 'image into three levels: "excellent", "good", and "poor" based on the proportion of small squares evaluated as "clear" among the 25 squares in each image: "excellent" is defined as the proportion of "clear" small squares ≥ 80%; The definition of "good" image quality is that the proportion of "clear" small squares is\>60% but\<80%; The definition of "poor" image quality is that the proportion of "clear" small squares is less than 60%; Calculate the proportion of images with "excellent" and "good" imaging quality to all images.

  through study completion, an average of half year

Secondary Outcomes (5)

• Repeatability of cell analysis function

  through study completion, an average of half year

• Repeatability of vascular blood flow analysis function

  through study completion, an average of half year

• Satisfaction rate of device performance and operational evaluation

  through study completion, an average of half year

• Satisfaction rate of clinical function and applicability evaluation of devices

  through study completion, an average of half year

• Adverse event occurrence rate

  through study completion, an average of half year

Interventions

No intervention measures OTHER

No intervention measures

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

randomly invited volunteers from primary eyecare outpatient patients or accompanying family members who meet the inclusion criteria

You may qualify if:

• 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)

You may not qualify if:

• 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
• \) 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;

Sponsors & Collaborators

• Robotrak Technologies Co., Ltd.: lead

Study Sites (1)

Robotrak Technologies Co., Ltd.

Nanjing, China

Location

MeSH Terms

Conditions

Retinal Diseases; Eye Diseases

Study Officials

• Qian Liu, O.D.

  Henan Provincial Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 15, 2023
• Study Start: July 5, 2023
• Primary Completion: October 31, 2023
• Study Completion: November 16, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)