NCT04328207

Brief Summary

Glaucoma is a blinding eye disease increasingly common in older adults, particularly in African Americans, and often diagnosed late in the disease course. It is essential to develop novel health care models, utilizing telemedicine, to improve the ability to detect glaucoma at an earlier stage, and to provide a platform to manage this disease in community-based clinics so that further vision loss is prevented. Our goal is to improve the quality and accessibility of glaucoma detection and management among a vulnerable and at-risk segment of our population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

November 18, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 25, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

March 27, 2020

Results QC Date

June 18, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

telemedicineteleophthalmologytelehealthteleglaucomafinancial incentives

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants That Adhere to Referral Appointment

    The percentage of patients who adhere to attending their referral appointments who received a financial incentive and eye health education will be compared with the percentage of patients who adhere to attending their referral appointments who received standard of care eye health education alone and no financial incentive for completing a referral visit.

    The time frame will be whether they attended the referral appointment between the screening date until 6 months after the screening date.

Study Arms (2)

No financial incentive

OTHER

This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit.

Other: No Financial Incentive

Financial incentive

EXPERIMENTAL

This group will receive a financial incentive once the referral visit is completed (if one was required) as well as eye health education.

Behavioral: Financial Incentive

Interventions

Standard of care eye health education

Also known as: Standard of Care
No financial incentive

Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed.

Financial incentive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American or Hispanic ≥40 years
  • Non-Hispanic white ≥50 years
  • Anyone ≥ 18 years with diabetes
  • Anyone ≥ 18 years with a glaucoma associated diagnosis
  • Anyone ≥ 18 years with a family history of glaucoma
  • All enrollees must be able to speak and understand English

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

  • Rhodes LA, Register S, Asif I, McGwin G Jr, Saaddine J, Nghiem VTH, Owsley C, Girkin CA. Alabama Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (AL-SIGHT): Study Design and Methodology. J Glaucoma. 2021 May 1;30(5):371-379. doi: 10.1097/IJG.0000000000001794.

Related Links

MeSH Terms

Conditions

GlaucomaDiabetic RetinopathyRefractive ErrorsCataractHealth Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesRetinal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesLens DiseasesBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Cynthia Owsley
Organization
University of Alabama at Birmingham

Study Officials

  • Christopher A Girkin, MD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigators are masked as to which group the patient is in.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: In the first half of enrollment in the program there will be no financial incentive offered to any patients. In the second half of enrollment, all patients needing referral will be notified that they will receive a payment upon the completion of their referral visit.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

November 18, 2020

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

August 7, 2025

Results First Posted

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

To be determined at a later point.

Locations