Diabetic RetinopathySC-DRAINCT03912961
The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study
An observational study of Diabetic Retinopathy, run by Retina Global at 3 sites in Bolivia.
Trial summary
In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Picture of the retina with a handheld retinal camera
- How many people
- 1,034 participants
- Where
- 3 sitesBolivia
- Study dates
- 21 Jan 2019to 15 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are known diabetics in the hospital, or seeking help from the eye clinics or from associated specialties, e.g. endocrinology, will be included in the study as subjects. The Investigators will also recruit subjects who are evaluated in organized outreach visits in the community.
Who may be able to join
- Male or female subjects who are at least 18 years old who have full legal capacity to volunteer on the date the informed consent is signed;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates;
- Subjects who have been diagnosed with Type I or Type II diabetes mellitus.
Who cannot join
- Subjects unable to tolerate ophthalmic imaging;
- Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy.
- Subject blind in one eye due to any cause
- Subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Trial locations and contacts
3 sites in 1 country.
Bolivia3 sites
Centro Medico Kolping
Santa Cruz de la Sierra
Clinica Incor
Santa Cruz de la Sierra
Hospital Universitario Japones
Santa Cruz de la Sierra
About this study
Official title: Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar's Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera
In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.
- Conditions
- Diabetic Retinopathy
- Being tested
- Picture of the retina with a handheld retinal camera
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picture of the retina with a handheld retinal cameraOther
Patient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease
To quantify image analysis performance of the EyeStar AI system paired with Pictor Plus cameras for the detection of referable Diabetic Retinopathy (DR), defined as severe non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), or diabetic macular edema (DME) against adjudicated reads of retinal images by retina specialists
Measured: 3 months
Secondary outcomes (2)
Number of subjects with gradable images taken by the hand held camera
Pictures taken by the handheld retinal camera will be graded by the retina specialists for the quality of image for readouts
Measured: 3 months
Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists
To assess the performance of the system in detection of other ocular diseases such as macular degeneration and glaucoma
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start21 Jan 2019
- Primary completion14 Apr 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Global
- Sponsor type
- University, hospital or other
- Collaborators
- VisionQuest Biomedical LLC
- Responsible party
- Sponsor
- Investigators
- Rajat Agrawal, MD MS, Study director, Retina Global
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912961
- Sponsor's protocol ID
- 2019-BOL-SC-DRAI
- Acronym
- SC-DRAI
- Status last verified
- Jun 2020
- First submitted
- 13 Mar 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar's Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera
- ClinicalTrials.gov ID
- NCT03912961
- Acronym / sponsor ID
- SC-DRAI / 2019-BOL-SC-DRAI
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- Retina GlobalUniversity, hospital or other
- Collaborators
- VisionQuest Biomedical LLC
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 11 Apr 2019 (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.
In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are known diabetics in the hospital, or seeking help from the eye clinics or from associated specialties, e.g. endocrinology, will be included in the study as subjects. The Investigators will also recruit subjects who are evaluated in organized outreach visits in the community.
Key inclusion criteria (3 listed)
- Male or female subjects who are at least 18 years old who have full legal capacity to volunteer on the date the informed consent is signed;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates;
- Subjects who have been diagnosed with Type I or Type II diabetes mellitus.
Key exclusion criteria (4 listed)
- Subjects unable to tolerate ophthalmic imaging;
- Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy.
- Subject blind in one eye due to any cause
- Subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
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 |
|---|---|---|
| Picture of the retina with a handheld retinal cameraPatient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc. | Other | – |
Primary outcome
Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease
Time frame: 3 months
To quantify image analysis performance of the EyeStar AI system paired with Pictor Plus cameras for the detection of referable Diabetic Retinopathy (DR), defined as severe non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), or diabetic macular edema (DME) against adjudicated reads of retinal images by retina specialists
2 secondary outcomes
Number of subjects with gradable images taken by the hand held camera
Time frame: 3 months
Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists
Time frame: 3 months
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 5 Jun 2020.
- Individual participant dataSharing planned: No
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A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
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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.
Rajat Agrawal, MD MS study director
Retina Global
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Retina Global at 3 sites in Bolivia.
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 4 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 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bolivia. 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?
Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease (time frame: 3 months). 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 5 Jun 2020; AzTrials last refreshed its copy on 3 Nov 2026.