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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention measures | Other | No intervention measures |
| 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 |
| 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. |
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Inclusion criteria：
exclusion criteria：
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;
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randomly invited volunteers from primary eyecare outpatient patients or accompanying family members who meet the inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Qian Liu, O.D. | Henan Provincial Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robotrak Technologies Co., Ltd. | Nanjing | China |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| 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 |