Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial (CORE-RCT)

UMC Utrecht

Status: Active, not recruiting

Conditions: Cataract

Treatments: Other: remote monitoring after cataract surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04809402

NL74625.041.20

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Telemonitoring

Other group

Description:

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

Treatment:

Other: remote monitoring after cataract surgery

Usual care

No Intervention group

Description:

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