Clinical trial NCT06173414: Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
Official title: Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Disease
Healthy
Keywords: healthy patients
eye disease
Lead sponsor: Robotrak Technologies Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: randomly invited volunteers from primary eyecare outpatient patients or accompanying family members who meet the inclusion criteria

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.

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 criteria: 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;

Primary outcomes:
measure: Image quality excellence rate
timeFrame: through study completion, an average of half year
Secondary outcomes:
measure: Repeatability of cell analysis function
timeFrame: through study completion, an average of half year
measure: Repeatability of vascular blood flow analysis function
timeFrame: through study completion, an average of half year
measure: Satisfaction rate of device performance and operational evaluation
timeFrame: through study completion, an average of half year
measure: Satisfaction rate of clinical function and applicability evaluation of devices
timeFrame: through study completion, an average of half year
measure: Adverse event occurrence rate
timeFrame: through study completion, an average of half year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Robotrak Technologies Co., Ltd.
Study officials:
affiliation: Henan Provincial Eye Hospital
name: Qian Liu, O.D.
role: PRINCIPAL_INVESTIGATOR
References: