Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DP006827-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| University of California, San Diego | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if implementation of an eye screening program at Federally Qualified Health Center (FQHC) clinics provides results that participants may have glaucoma, and/or other eye conditions (diabetic retinopathy, cataract, visual acuity impairment). The glaucoma screening will incorporate use of an artificial intelligence (AI)-assisted screening tool. This project is called AI-RONA. The main questions it aims to answer are:
Participants will:
Federally Qualified Health Center (FQHC) clinics are excellent candidate clinics for eye disease screening programs for adults, including glaucoma and also other glaucoma associated diseases (GAD), diabetic retinopathy, cataract and refractive error. These clinics are safety-net primary health care clinics in the United States designed to serve medically underserved areas and populations. The physician will provide services regardless of the patient's ability to pay, using a sliding-scale fee based on the ability to pay. Over half the patient population at FQHCs nationally is Black or Hispanic, with 82% of patients uninsured or federally insured. While FQHCs provide primary medical care in many health domains, one domain that is not adequately addressed by FQHC clinics is eye care. A recent report by the National Academies of Science, Engineering and Medicine indicated that primary eye care services (through optometrists or ophthalmologists) are rarely available at FQHC clinics; the report provided an estimate that less than 3% of FQHC patients actually receive vision care services at these clinics, representing 0.89% of FQHC clinic visits.
The screening methods used in this protocol are a modified version of our prior imaging-based ophthalmologist guided telemedicine screening protocol utilized in the previous CDC- funded Alabama Screening and Intervention for Glaucoma and eye Health through Telemedicine (AL-SIGHT) study. In AL-SIGHT we used a telemedicine program to screen for glaucoma in 3 FQHCs located in a low-income, under-resourced region of the state with a high proportion of Black residents. Just as we did in AL-SIGHT, investigators in the current protocol will target screening only for those FQHC patients at-risk for glaucoma. The eligibility definition for screening in the current project is listed under Eligibility.
After screening, patients with a screening diagnosis of GAD, diabetic retinopathy, cataract, or visual acuity impairment will be referred for an in-person follow-up exam by an ophthalmologist or optometrist located in the FQHC clinic's region. In the investigators' previous project, participants had excellent adherence to the follow-up appointment with the optometrist or ophthalmology at a rate of 76.7% of patients attending follow-up. Thus, Investigators are hopeful that in the current project they will also have this high level of adherence.
There are two major differences between our previous project (AL-SIGHT) and the current project AI-RONA. In AL-SIGHT, we used research staff members to do the screening at the FQHCs. In AI-RONA investigators will now use implementation science to do the screening. This means that investigators will train the FQHC clinic staff to do the screening after a detailed training and certification program. A second way AI-RONA differs from AL-SIGHT is that investigators will use an AI-assisted, remote screening algorithm to generate the screening results for glaucoma. Investigators will also focus on both the effectiveness of the program (disease detection, rate of referrals) and primary care providers (PCPs) and patients' attitudes about AI-RONA. The latter will be achieved by administering a questionnaire to PCPs and to participants about their satisfaction with the screening program.
The AI approaches to be deployed for AI-RONA have been previously developed and extensively tested by the AI-researchers at the University of California, San Diego, who are also investigators in AI-RONA. It was found that glaucoma testing using AI based on retinal images taken of patients' eyes lead to clinician-level accuracy. These AI methodologies have been tested on diverse populations and publicly available datasets to facilitate their accuracy.
The eye screen protocol that investigators are using includes the following. All assessments are performed on each eye separately: (1) retinal imaging including fundus photography and optical coherence tomography (OCT), (2) visual acuity measurement, (3) refractive error measurement.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Federally Qualified Health Centers (FQHCs) | Experimental | Eight FQHCs will participate in this project. Four FQHCs will implement a glaucoma screening protocol and a protocol for detecting diabetic retinopathy, cataract, and visual acuity impairment, while the other four will be standard of care without the above screening protocol. |
|
| Primary Standard of Care | No Intervention | Primary care provider asks participants if they are having symptoms or problems with their eyes or vision. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glaucoma screening using an AI-algorithm and screening for diabetic retinopathy, cataract, and visual acuity impairment. | Other | Participants who have the glaucoma screening will undergo an Artificial Intelligence Remote Optic Nerve Assessment (AI-RONA). The AI information may or may not be used by the FQHC provider to refer their patient for follow-up eye exam. It is information that the provider may find useful in making a referral. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participants where the glaucoma screening protocol leads to a screening diagnosis of glaucoma | Primary care provider will make a screening diagnosis of glaucoma associated disease based on the results of the screening | up to 2-3 days |
| Rate of participants who decide to attend the follow up exam by optometrist or ophthalmologist | If diagnosed with any of the above conditions, and primary car provider recommends follow-up care with an optometrist or ophthalmologist, whether participant actually attends the exam | up to 4 months |
| Rate of participants where the screening protocol leads to a screening diagnosis of cataract, diabetic retinopathy, or visual acuity impairment | Based on results of screening, the primary care provider will be able to make a screening diagnosis of cataract, diabetic retinopathy or visual acuity impairment | up to 2-3 days |
| Compare cost of screening program in FQHC to the cost of an ophthalmologist or optometrist guided assessment | Compare the cost of AI based interventions relying on optic disc photos alone, OCT alone, both imaging modalities, and imaging with standard vision tests performed by an ophthalmologist or optometrist guided program | up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of primary care provider who state they agree with intervention acceptability, appropriateness, and feasibility | Whether the primary care provider agrees with the eye screening program per the Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure; scores range from 16 to 80 with higher scores meaning more agreement | up to 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Owsley, PhD | Contact | 205-325-8635 | cynthiaowsley@uabmc.edu | |
| Dawn Matthies, PhD | Contact | 205-325-8631 | dmatthies@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cynthia Owsley, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294-0009 | United States |
de-identified data will be shared.
September 29, 2029
Scientists who work in the field of glaucoma screening and other types of eye screening will be able to access the supporting information described above. They can access this information by contacting the principal investigator.
Not provided
The initial design implements the eye screening intervention in 4 FHQC clinics operated by Southeast Alabama Rural Health Associates (SARHA) for a duration of 18 months. Four other FQHC clinics operated by SARHA are the control, or non-interventional clinics, which are followed during the same time period. After 18 months the control clinics become the interventional clinics and the previous intervention clinics become the control clinics.
Not provided
Not provided
Not provided
Not provided
|
| Rate of participants who state they agree with the acceptability of the screening intervention | Whether the participant agrees with the acceptability of eye screening per Post AI-RONA Screening questionnaire; scores range from 9 to 45 with higher scores meaning more agreement | up to 1 day |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D003930 | Diabetic Retinopathy |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D007905 | Lens Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
Not provided
Not provided