Clinical trial NCT04809402: Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial
Official title: Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: e-health
digital
remote monitoring
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Health Holland
First posted: 2021-03-22
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cost-effectiveness
timeFrame: pre-operative until 3 months after surgery
Secondary outcomes:
measure: Corrected distance visual acuity at the final post-operative visit (achieved with web-based vs manifest refraction)
timeFrame: 4-6 weeks after surgery
measure: Uncorrected distance visual acuity (web-based vs reference chart)
timeFrame: pre-operative, 4-6 weeks after surgery
measure: Refractive error in sphere/cylinder/axes (web-based vs reference chart)
timeFrame: 4-6 weeks after surgery
measure: Patient reported outcomes
timeFrame: pre-operative vs 3 months after surgery
measure: Adverse events / additional consultations
timeFrame: pre-operative until 3 months after surgery
measure: Total costs
timeFrame: pre-operative until 3 months after surgery
measure: QALY's
timeFrame: pre-operative and 3 months after surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery, Austria
city: Sulzbach
country: Germany
facility: Augenklink Sulzbach
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: Noord-Brabant
city: Heerhugowaard
country: Netherlands
facility: Oogcentrum Noordholland
state: Noord-Holland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Utrecht
country: Netherlands
facility: Janneau Claessens
Study officials:
References: