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.

Study Overview

• Status: Completed
• Conditions: Healthy; Retinal Disease
• Intervention / Treatment: Other: No intervention measures

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

• Study Type: Observational
• Enrollment (Actual): 194

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Robotrak Technologies Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability of cell analysis function	The Adaptive Optics ScanningLaser Ophthalmoscope by Robotrak Technologies Co., Ltd. has image post-processing function, which can analyze single cell images, generate photoreceptor cell density, photoreceptor cell spacing, photoreceptor cell regularity, and photoreceptor cell dispersion. The operator collected images of the photoreceptor cell layer from three positions in the subject's retina (8.8 ° above the fovea of the macula and 8.8 ° below the fovea of the macula), with 5 independent images collected from each position. Repeatability evaluation using ICC intra group correlation coefficients after removing the highest and lowest values.	through study completion, an average of half year
Repeatability of vascular blood flow analysis function	The Adaptive Optics ScanningLaser Ophthalmoscope by Robotrak Technologies Co., Ltd. can obtain quantitative blood flow indicators such as vascular wall thickness, vascular diameter, lumen diameter, wall/lumen ratio, vascular wall cross-sectional area, and blood flow velocity. The operator collected 5 independent images of the subject's retina at the same position and vascular level, and recorded the above information generated by the machine. After removing the highest and lowest values, the ICC intra group correlation coefficient was used to evaluate repeatability.	through study completion, an average of half year
Satisfaction rate of device performance and operational evaluation	The operator evaluates the performance and operation of the device on a scale based on the usage situation after the inspection is completed.	through study completion, an average of half year
Satisfaction rate of clinical function and applicability evaluation of devices	The operator evaluates the clinical function and applicability of the adaptive optical fundus imaging system for fundus examination using a scale based on usage.	through study completion, an average of half year
Adverse event occurrence rate	The incidence of adverse events, including but not limited to the following possible adverse events: Eye surface damage: During multifocal electroretinogram examination, corneal electrodes need to be worn on the cornea, which may cause eye surface damage. If corneal injury or severe conjunctival congestion occurs, topical eye drops can be used to combat infection and promote corneal epithelial repair. Eye fatigue: During the examination process, subjects may experience eye fatigue due to measuring the brightness of the light source. Generally, it can improve after a brief rest Infection: Due to insufficient cleaning and disinfection of the collar and forehead pads under the device, repeated use may cause cross infection of the subject's skin. Once an infection is detected, symptomatic treatment is sufficient.	through study completion, an average of half year

Collaborators and Investigators

• Sponsor: Robotrak Technologies Co., Ltd.
• Investigators: Principal Investigator: Qian Liu, O.D., Henan Provincial Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: eye disease; healthy patients
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: RT-MONA-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No