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Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

NCT04809402 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2023-06-01

No results posted yet for this study

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

OTHER

remote monitoring after cataract surgery

remote monitoring after cataract surgery

Sponsors & Collaborators

  • Health Holland

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2023-05-10
Completion
2023-07-22

Countries

  • Austria
  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809402 on ClinicalTrials.gov