Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

  • STATUS
    Recruiting
  • End date
    Apr 5, 2023
  • participants needed
    94
  • sponsor
    UMC Utrecht
Updated on 4 October 2022

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.

Details
Condition Cataract, Cataracts, Cataracts
Treatment remote monitoring after cataract surgery
Clinical Study IdentifierNCT04809402
SponsorUMC Utrecht
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Planned for bilateral phacoemulsification cataract extraction and intra-ocular lens implantation (either sequentialor in one procedure)
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

Exclusion Criteria

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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