Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Health Holland | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring | Other | Subjects in the telemonitoring group will have post-operative follow-up measurements involving teleconsultations, remote eye exams and health questionnaires. |
|
| Usual care | No Intervention | Subjects in the usual care group will receive regular post-operative care, mostly involving in-hospital consultations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote monitoring after cataract surgery | Other | remote monitoring after cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | The main outcome measure will be Incremental cost-effectiveness ratio (ICER), defined as euros per QALY, and compared between the two groups. | pre-operative until 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-6 weeks after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Institute for Research in Ocular Surgery, Austria | Vienna | Austria | ||||
| Augenklink Sulzbach |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38809014 | Derived | 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. | |
| 37010267 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| pre-operative, 4-6 weeks after surgery |
| 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. | 4-6 weeks after surgery |
| 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. | pre-operative vs 3 months after surgery |
| 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. | pre-operative until 3 months after surgery |
| 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). | pre-operative until 3 months after surgery |
| 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. | pre-operative and 3 months after surgery |
| Sulzbach |
| Germany |
| Amphia Ziekenhuis | Breda | North Brabant | 4818CK | Netherlands |
| Oogcentrum Noordholland | Heerhugowaard | North Holland | 1704 AG | Netherlands |
| Maastricht UMC+ | Maastricht | Netherlands |
| Janneau Claessens | Utrecht | 3508 GA | Netherlands |
| Derived |
| 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. |
| 36717799 | Derived | 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. |