NCT04809402

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
3 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

March 10, 2021

Last Update Submit

May 31, 2023

Conditions

Cataract

Keywords

e-healthdigitalremote monitoring

Outcome Measures

Primary Outcomes (1)

  • Cost-effectiveness

    The main outcome measure will be Incremental cost-effectiveness ratio (ICER), defined as euros per QALY, and compared between the two groups.

    pre-operative until 3 months after surgery

Secondary Outcomes (7)

  • Corrected distance visual acuity at the final post-operative visit (achieved with web-based vs manifest refraction)

    4-6 weeks after surgery

  • Uncorrected distance visual acuity (web-based vs reference chart)

    pre-operative, 4-6 weeks after surgery

  • Refractive error in sphere/cylinder/axes (web-based vs reference chart)

    4-6 weeks after surgery

  • Patient reported outcomes

    pre-operative vs 3 months after surgery

  • Adverse events / additional consultations

    pre-operative until 3 months after surgery

  • +2 more secondary outcomes

Study Arms (2)

Telemonitoring

OTHER

Subjects in the telemonitoring group will have post-operative follow-up measurements involving teleconsultations, remote eye exams and health questionnaires.

Other: remote monitoring after cataract surgery

Usual care

NO INTERVENTION

Subjects in the usual care group will receive regular post-operative care, mostly involving in-hospital consultations.

Interventions

remote monitoring after cataract surgeryOTHER

remote monitoring after cataract surgery

Telemonitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned for bilateral phacoemulsification cataract extraction and intra-ocular lens implantation (either sequentialor in one procedure)
  • ≥ 18 years of age
  • No other current ophthalmic conditions or history that negatively influence post-operative visual acuity
  • Be able to fill out the health questionnaires (in Dutch, German or English) and perform the web-based refractiveassessment (possibly with assistance of family member or other close relative).
  • Specific digital requirements include access to a computer and a smartphone and knowledge how to log in to anonline patient portal.

You may not qualify if:

  • Cataract extraction surgery combined with other procedures, including: keratoplasty, vitrectomy, glaucoma filter implants
  • Ocular comorbidities that negatively influence post-operative visual acuity
  • No access to the digital requirements to take the online health questionnaire and/or perform the online refraction.
  • Insufficient command of the Dutch, German or English language to understand the questionnaires andinstructions of the web-based refractive assessment or no family member / close relative to assist with this
  • Inability of performing the web-based eye exam prior to cataract surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Vienna Institute for Research in Ocular Surgery, Austria

Vienna, Austria

Location

Augenklink Sulzbach

Sulzbach, Germany

Location

Amphia Ziekenhuis

Breda, North Brabant, 4818CK, Netherlands

Location

Oogcentrum Noordholland

Heerhugowaard, North Holland, 1704 AG, Netherlands

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Janneau Claessens

Utrecht, 3508 GA, Netherlands

Location

Related Publications (3)

  • Claessens JLJ, Wanten JC, Bauer NJC, Nuijts RMMA, Vrijman V, Selek E, Wouters RJ, Reus NJ, van Dorst FJGM, Findl O, Ruiss M, Boden K, Januschowski K, Imhof SM, Wisse RPL. Web-based telemonitoring of visual function and self-reported postoperative outcomes in cataract care: international multicenter randomized controlled trial. J Cataract Refract Surg. 2024 Sep 1;50(9):947-955. doi: 10.1097/j.jcrs.0000000000001492.

    PMID: 38809014DERIVED

  • Claessens JLJ, Maats EPE, Iacob ME, Wisse RPL, Jongsma KR. Introducing e-health technology to routine cataract care: patient perspectives on web-based eye test for postoperative telemonitoring. J Cataract Refract Surg. 2023 Jul 1;49(7):659-665. doi: 10.1097/j.jcrs.0000000000001189. Epub 2023 Mar 29.

    PMID: 37010267DERIVED

  • Claessens JLJ, Wanten JC, Bauer NJC, Nuijts RMMA, Findl O, Huemer J, Imhof SM, Wisse RPL. Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial. BMC Ophthalmol. 2023 Jan 30;23(1):41. doi: 10.1186/s12886-023-02779-7.

    PMID: 36717799DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 22, 2021

Study Start

April 19, 2021

Primary Completion

May 10, 2023

Study Completion

July 22, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

AU(1)NL(4)DE(1)