Retinal DiseaseNCT06173414
Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
An observational study of Retinal Disease and Healthy, run by Robotrak Technologies Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Healthy
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to 16 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: randomly invited volunteers from primary eyecare outpatient patients or accompanying family members who meet the inclusion criteria
Who may be able to join
- 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)
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Retinal Disease, Healthy
- Being tested
- No intervention measures
- Keywords
- healthy patients, eye disease
- Medical subject headings
- Retinal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention measuresOther
No intervention measures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of half year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start5 Jul 2023
- Primary completion31 Oct 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robotrak Technologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qian Liu, O.D., Principal investigator, Henan Provincial Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173414
- Sponsor's protocol ID
- RT-MONA-2023-01
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial
- ClinicalTrials.gov ID
- NCT06173414
- Acronym / sponsor ID
- RT-MONA-2023-01
- Conditions
- Retinal Disease, Healthy
- Keywords
- healthy patients, eye disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Robotrak Technologies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- randomly invited volunteers from primary eyecare outpatient patients or accompanying family members who meet the inclusion criteria
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention measuresNo intervention measures | Other | – |
Primary outcome
Image quality excellence rate
Time frame: through study completion, an average of half year
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.
5 secondary outcomes
Repeatability of cell analysis function
Time frame: through study completion, an average of half year
Repeatability of vascular blood flow analysis function
Time frame: through study completion, an average of half year
Satisfaction rate of device performance and operational evaluation
Time frame: through study completion, an average of half year
Satisfaction rate of clinical function and applicability evaluation of devices
Time frame: through study completion, an average of half year
Adverse event occurrence rate
Time frame: through study completion, an average of half year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No. Not yet decided
Related trials for Retinal Disease
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Liu, O.D. principal investigator
Henan Provincial Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease and Healthy, run by Robotrak Technologies Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality excellence rate (time frame: through study completion, an average of half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.