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Validation of the Dutch Patient-Reported Spectacle Independence Questionnaire (PRSIQ)

Validation of the Dutch Patient-Reported Spectacle Independence Questionnaire (PRSIQ)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21890
Enrollment
400
Registered
2020-08-04
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cataract

Interventions

Cataract patients will fill in the PRSIQ-NL questionnaire before and 3 months after surgery. Half of them will fill in a second PRSIQ-NL questionnaire, both preoperatively and postoperatively, to asse

Sponsors

Relationship between spectacle dependency, as assessed with PRSIQ-NL, and visual functioning, as assessed with Catquest-9SF-NL, after cataract surgery.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cataract patients: age of at least 18 years, diagnosis of cataract in both eyes, having consented to and is planned to undergo cataract surgery in both eyes, expected best-corrected distance Snellen decimal visual acuity of 0.7 or better in each eye, planned for implantation in both eyes of a a) non-toric monofocal IOL with target emmetropia, b) non-toxic monofocal IOL with target mild myopia, c) toric monofocal IOL with target emmetropia, d) non-toric enhanced far-focus IOL, e) extended depth of focus IOL with target emmetropia or monovision, f) trifocal IOL with target emmetropia, willing and able to participate in both preoperatieve and postoperative examination, and agreeing to sign the consent form. Healthy subjects: age of at least 18 years, no ocular or visual complaints (other than using spectacles or contact lenses), no significant history of ocular disease (including cataract, corneal disease, glaucoma, and posterior segment eye disease), no history of ocular surgery (including cataract surgery and corneal refractive surgery), willing and able to participate in examinations, and agreeing to sign the consent form.

Exclusion criteria

Exclusion criteria: Cataract patients: insufficient understanding of the Dutch language to comply with study procedures, best-corrected distance Snellen decimal visual acuity of <0.7 in either eye after cataract surgery, any comorbidity (other than cataract) that may significantly affect visual function, influence subjective ocular visual symptoms, or prolong visual recovery after surgery, such as significant macular degeneration, glaucoma, diabetic eye disease, ocular surface disease, corneal dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident, a history of ocular surgery (e.g., corneal refractive surgery), an increased risk of complicated cataract surgery, such as lens subluxation or (phaco)iridodonesis, brunescens cataract, rubra cataract, ingrains cataract, or posterior pole cataract, history of ocular trauma, and a complication, either perioperatively or postoperatively, that significantly affects vision and has not resolved before 3 months after surgery. Healthy subjects: insufficient understanding of the Dutch language to comply with study procedures.

Design outcomes

Primary

MeasureTime frame
Validation of the Dutch version of the PRSIQ by means of Rasch analysis and item response theory (IRT) analysis and test-retest reliability.

Secondary

MeasureTime frame
Differences in Rasch and IRT scores between groups of patients with different types of IOLs, patients with different set refractive targets and healthy subjects.

Contacts

Public ContactNic Reus

Amphia Ziekenhuis

nreus@amphia.nl0031765952239

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)