Community-based implementation and feasibility of portable ophthalmic diagnostic devices: a quasi-experimental pre-post study in underserved areas

Portable ophthalmic diagnostic devices have emerged as promising tools to improve access to eye care in underserved communities; however, their agreement with conventional equipment and real-world implementation feasibility remain insufficiently evaluated. This study aimed to evaluate the diagnostic agreement of two portable ophthalmic devices and their real-world implementation feasibility in an underserved rural community. We conducted a two-phase study consisting of an in-hospital agreement study and a community-based implementation study. In the in-hospital phase, a smartphone-based portable slit lamp (TopSlit) and a handheld all-in-one imaging device (Reticapture) were compared with conventional stationary equipment in 72 patients with ocular diseases. Agreement was assessed using Cohen’s κ, intraclass correlation coefficients (ICC), and Spearman’s correlation. In the community-based phase, 124 residents aged ≥ 60 years from 10 underserved rural villages underwent baseline ophthalmic screening and a 6-month follow-up assessment. The primary endpoint was the 30-day hospital-visit completion rate among referred participants; secondary outcomes assessed implementation feasibility and participant acceptability, while longitudinal visual-acuity and patient-reported outcomes were exploratory. TopSlit and Reticapture showed moderate to almost perfect agreement with conventional reference equipment (κ = 0.535–0.944). Among 60 participants referred for further evaluation, the 30-day hospital-visit completion rate was 53.3% (32/60; 95% CI, 40.9–65.4%), exceeding the prespecified 40% feasibility threshold (exact p = 0.047). No upload/network or image-quality failures occurred during field implementation, and no additional image reacquisition or remote-grader requests for additional images were required. Participant satisfaction with the program was high (92.9%). These findings support the feasibility and acceptability of integrating portable ophthalmic devices into a community-based eye-care program in an underserved rural setting. The observed agreement with conventional reference equipment, operational performance, and linkage to follow-up care support further evaluation in larger, rigorously controlled studies. The study was approved by the Dankook University Hospital IRB (DKUH IRB 2022-10-016 (Date of Registration: 2022-10-13; Date of Approval: 2022-11-10) and DKUH IRB 2024-06-016 (Date of Registration: 2024-06-13; Date of Approval: 2024-08-02)). The study was registered at the Clinical Research Information Service (CRIS), Republic of Korea ( https://cris.nih.go.kr ; KCT0012177).