Digital Health Support for Cataract Surgery With the Sharp Health Companion CareKit App: Randomized Controlled Trial

Cataract surgery is the most frequently performed surgery worldwide, crucial for restoring sight in millions. The COVID-19 pandemic and an aging population have increased barriers to timely surgery. Missed preoperative instructions and poor adherence to postoperative care contribute to surgery cancellations, delays, and potential complications. Mobile digital health interventions could enhance adherence and reduce cancellations.

This study assessed the effectiveness of the Sharp Health Companion smartphone app, built on the CareKit health platform, compared with printed instructions. The aim was to evaluate its impact on medication adherence, surgery delays and cancellations, visual outcomes, and patient experience among older adults undergoing cataract surgery.

In this randomized controlled trial, 200 patients aged 41-87 (mean 69, SD 8.2) years were enrolled at a high-volume ophthalmology practice between December 2022 and January 2024. Most participants (145/200, 73%) were 65 years or older. Patients were randomized to group 1 (printed instructions with phone reminders, n=104) or group 2 (Sharp Health Companion app supplemented with backup printed instructions, n=96). Both groups received identical perioperative instructions and medications. Data included demographics, visual acuity, medication adherence (self-reported by paper checklist or Sharp Health Companion app care-card checklist and eye medication bottle weights), surgery cancellations and delays, and satisfaction surveys administered preoperatively, on postoperative day 1, and at 30 days.

Sharp Health Companion app users had fewer same-day surgery delays (1/96, 1%) than those receiving printed instructions (10/104, 10%; P=.01), while cancellation rates were similar (P=.33). Patient-reported preparedness for surgery was high and comparable between groups on postoperative day 1 (group 1: mean 9.56, SD 1.19; group 2: 9.77, SD 0.73; P=.16). Preparedness for recovery at postoperative month 1 was similarly high (mean 9.92, SD 0.37 vs mean 9.85, SD 0.47; P=.28). At 30 days postoperatively, visual acuity improvement was similar (mean 0.14, SD 0.17 vs mean 0.11, SD 0.13 logarithm of the minimum angle of resolution; P=.13), and complications were rare (iritis 2/98, 2% vs 1/87,1%; cystoid macular edema 1/98, 1% vs 1/87, 1%). Self-reported medication adherence favored printed instruction users (66/68, 97% vs 47/64, 73%; P<.001), whereas objective antibiotic-drop adherence favored app users (mean 5.36, SD 1.17 g vs mean 5.67, SD 1.00 g; P=.046).

The Sharp Health Companion app reduced same-day surgery delays and improved patient experience while supporting objective medication adherence in predominantly older adults undergoing cataract surgery. These findings suggest mobile health interventions can enhance perioperative care and efficiency, even in populations less familiar with technology.

ClinicalTrials.gov NCT07028359; https://clinicaltrials.gov/ct2/show/NCT07028359.