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CataractCORE-RCTNCT04809402

Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

A study testing remote monitoring after cataract surgery in people with Cataract, run by UMC Utrecht at 6 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract
What is being tested?
remote monitoring after cataract surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
6 sitesin 3 countries
Study dates
19 Apr 2021to 22 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Netherlands4 sites

  • Amphia Ziekenhuis

    Breda, North Brabant, 4818CK

  • Oogcentrum Noordholland

    Heerhugowaard, North Holland, 1704 AG

  • Maastricht UMC+

    Maastricht

  • Janneau Claessens

    Utrecht, 3508 GA

Other trials in Netherlands

Austria1 site

  • Vienna Institute for Research in Ocular Surgery, Austria

    Vienna

Other trials in Austria

Germany1 site

  • Augenklink Sulzbach

    Sulzbach

Other trials in Germany

About this study

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.

Read more

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
Being tested
remote monitoring after cataract surgery
Keywords
e-health, digital, remote monitoring
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remote monitoring after cataract surgeryOther

    remote monitoring after cataract surgery

Study groups in NCT04809402
Study groupRoleWhat they receive
TelemonitoringOtherSubjects in the telemonitoring group will have post-operative follow-up measurements involving teleconsultations, remote eye exams and health questionnaires.
Receives: Other: remote monitoring after cataract surgery
Usual careNo interventionSubjects in the usual care group will receive regular post-operative care, mostly involving in-hospital consultations.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: pre-operative until 3 months after surgery

Secondary outcomes (7)

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

    The corrected distance visual acuity achieved with the web-based refraction will be compared to the corrected distance visual acuity that is achieved with the subjective refraction.

    Measured: 4-6 weeks after surgery

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

    The uncorrected distance visual acuity that is assessed in the web-based assessment will be compared to the uncorrected distance visual acuity that is assessed using the reference chart.

    Measured: pre-operative, 4-6 weeks after surgery

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

    The refractive error (in sphere/cylinder/axes) will be asssessed by the web-based assessment and compared to the subjective refractive error assessment.

    Measured: 4-6 weeks after surgery

  4. Patient reported outcomes

    The PROMs questionnaire (CatQuest-9SF) assesses the patient's own reported visual disability from cataract and the improvement after surgery. High scores represent better visual acuity. The results of the PROMs questionnaire will be compared between the groups to assess differences and determine if a web-based follow-up strategy influences these subjective measures. PROMs will be offered in Dutch, German or English accordingly and assessed at baseline and at 3 months follow-up.

    Measured: pre-operative vs 3 months after surgery

  5. Adverse events / additional consultations

    All unplanned additional consultations (telephone or hospital) will be recorded. We will count these and compare the frequencies between the two groups.

    Measured: pre-operative until 3 months after surgery

  6. Total costs

    Total costs (in euros) will be determined for both groups. We will count costs for hospital resources and staff, as well as costs for the patient (such as travel and parking costs).

    Measured: pre-operative until 3 months after surgery

  7. QALY's

    To determine the QALY, patients of both groups will be requested to fill out questionnaires to assess quality of life (EQ-5D). A unique health state is defined by combining one level from each of the five dimensions. Higher levels indicate more problems.

    Measured: pre-operative and 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start19 Apr 2021
  3. Primary completion10 May 2023
  4. Study completion22 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04809402
Sponsor's protocol ID
NL74625.041.20
Acronym
CORE-RCT
Status last verified
May 2023
First submitted
10 Mar 2021
Last updated
1 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38809014

  • 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.

    PubMed 37010267

  • 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.

    PubMed 36717799

Questions about this trial

What is this clinical trial studying?

A study testing remote monitoring after cataract surgery in people with Cataract, run by UMC Utrecht at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands, Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost-effectiveness (time frame: pre-operative until 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04809402, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.

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