NCT04809402: CORE-RCT

Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

Status unknown NA Last updated 1 June 2023

What this trial tests

NA trial testing remote monitoring after cataract surgery in Cataract in 94 participants. Status unknown.

Timeline

19 April 2021

Primary endpoint
10 May 2023

22 July 2023

Quick facts

Lead sponsor	UMC Utrecht
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	94
Start date	19 April 2021
Primary completion	10 May 2023
Estimated completion	22 July 2023
Sites	6 locations across Austria, Netherlands, Germany

Drugs / interventions tested

• remote monitoring after cataract surgery

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

UMC Utrecht — full company profile →

Who can join

18 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Introducing e-health technology to routine cataract care: patient perspectives on web-based eye test for postoperative telemonitoring.
   Claessens JLJ, Maats EPE, Iacob ME, Wisse RPL, et al · · 2023 · cited 6× · PMID 37010267 · DOI 10.1097/j.jcrs.0000000000001189
2. Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial.
   Claessens JLJ, Wanten JC, Bauer NJC, Nuijts RMMA, et al · · 2023 · cited 5× · PMID 36717799 · DOI 10.1186/s12886-023-02779-7
3. Web-based telemonitoring of visual function and self-reported postoperative outcomes in cataract care: international multicenter randomized controlled trial.
   Claessens JLJ, Wanten JC, Bauer NJC, Nuijts RMMA, et al · · 2024 · cited 4× · PMID 38809014 · DOI 10.1097/j.jcrs.0000000000001492