To determine non-inferiority of the corrected distance visual acuity (CDVA) with the prescription obtained through the web-based measurement of refractive error, compared to usual care, in patients who underwent routine cataract surgery.
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
costeffectiveness
Secondary outcome
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.
Background summary
Cataract is widely prevalent in especially elderly and cataract extraction
surgery has thus become one of the most performed surgeries worldwide. In
recent decades the safety of cataract surgery has greatly improved and it is
considered one of the safest surgeries to be performed. Postoperative
management consists of routine examinations within one week, to ascertain no
adverse events have occurred immediately after surgery, and between 4-6 weeks,
to determine the refractive error. The incidence of serious adverse events
following cataract surgery is estimated to be 1%. As a result, the majority of
patient visits after cataract surgery will be uneventful. Nonetheless valuable
time and hospital resources are consumed. Remote monitoring could replace
clinical examinations in selected patient groups. However, this practice of
digital remote monitoring which the patient can use independently has not been
clinically validated yet.
Study objective
To determine non-inferiority of the corrected distance visual acuity (CDVA)
with the prescription obtained through the web-based measurement of refractive
error, compared to usual care, in patients who underwent routine cataract
surgery.
Study design
Observational randomized trial without interventions
Intervention
Subjects in the telemonitoring group will have a post-operative follow-up by
teleconsultations with online questionnaires and a web-based eye exam.
Study burden and risks
The "telemonitoring group" will perform web-based eye exams and fill out
questionnaires at home at three time points after surgery. These take on
average 20 minutes each. All participants (both groups) will fill out
questionnaires on patient reported outcomes and quality of life, which take on
average 15 minutes. All patients will receive a final clinical assessment 4-6
weeks after surgery to validate the telemonitoring outcomes, mitigating the
risk of a residual refractive error after cataract surgery.
The risks are considered very low. The web-based eye exam has been tested and
proven safe (CE-certified). The subjects of the "telemonitoring group" will
have a telephonic consultation 1 day after surgery, this is in line with the
Dutch Society of Opthalmolgy guideline of cataract surgery. When there are
doubts, a physical consultation should be planed. After 4-6 weeks there will be
a physical consultation in the hospital.
Heidelberglaan 100
Utrecht 3583CX
NL
Heidelberglaan 100
Utrecht 3583CX
NL
Listed location countries
Age
Inclusion criteria
- Planned for bilateral phacoemulsification cataract extraction and
intra-ocular lens implantation (either sequential or 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 refractive assessment (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 an online 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 and instructions 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74625.041.20 |