NCT04809402

Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background of the study: Cataract is widely prevalent in especially elderly and cataract extraction surgery has thus become one of the most performedsurgeries worldwide. In recent decades the safety of cataract surgery has greatly improved and it is considered one of the safestsurgeries to be performed. Postoperative management consists of routine examinations within one week, to ascertain no adverseevents have occurred immediately after surgery, and between 4-6 weeks, to determine the refractive error. The incidence of seriousadverse events following cataract surgery is estimated to be 1%. As a result, the majority of patient visits after cataract surgery willbe uneventful. Nonetheless valuable time and hospital resources are consumed. Remote monitoring could replace clinicalexaminations in selected patient groups. However, this practice of digital remote monitoring which the patient can use independentlyhas not been clinically validated yet. Objective of the study: To determine non-inferiority of the corrected distance visual acuity (CDVA) with the prescription obtained through the web-basedmeasurement of refractive error, compared to usual care, in patients who underwent routine cataract surgery. Study design: Observational randomized trial without interventions Study population: Patients eligible for cataract surgery, without visual acuity influencing comorbidities or predisposing complicating factors. Primary study parameters/outcome of the study: costeffectiveness Secundary study parameters/outcome of the study (if applicable): Corrected distance visual acuity at the final post-operative visit, uncorrected distance visual acuity, refractive error(sphere/cylinder/axes), patient reported outcome measurements, adverse events.

Conditions

• Cataract

Interventions

Type	Name	Description
OTHER	remote monitoring after cataract surgery	remote monitoring after cataract surgery

Timeline

• Start date: 2021-04-19
• Primary completion: 2023-05-10
• Completion: 2023-07-22
• First posted: 2021-03-22
• Last updated: 2023-06-01

Locations

6 sites across 3 countries: Austria, Germany, Netherlands