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ID
Source
Brief title
Health condition
cataract
Sponsors and support
Intervention
Outcome measures
Primary outcome
Validation of the Dutch version of the PRSIQ by means of Rasch analysis and item response theory (IRT) analysis and test-retest reliability.
Secondary outcome
Differences in Rasch and IRT scores between groups of patients with different types of IOLs, patients with different set refractive targets and healthy subjects.
Background summary
Whether a patient will use spectacles after cataract surgery typically depends on the type of intraocular lens (IOL) implanted, any remaining refractive error, and personal preference of the patient. The Patient-Reported Spectacle Independence Questionnaire (PRSIQ) is a patient-reported outcome measure (PROM) that evaluates what patients say about their need for spectacles, what they use in daily life, and how they function without spectacles. More specifically, it contains a total of 11 questions on the need, use, and wear of spectacles to see at far, intermediate, and near. It is available in the English language and has been validated for use in the United States. Recently, we developed a formal Dutch translation of the questionnaire. Our main objective is to validate the Dutch translation of the PRSIQ and assess its test-retest reliability. Our secondary objective is to evaluate any differences in spectacle dependency between patients with different types of IOLs and healthy subjects of different ages. Our tertiairy objective is to assess the relationship between spectacle dependency and experienced visual functioning after cataract surgery, assessed with the Catquest-9SF-NL PROM.
Study objective
The PRSIQ-NL is a valid questionnaire to assess the need, use, and wear of spectacles to see at far, intermediate, and near in patients with cataract and healthy subjects.
Study design
Preoperatively and postoperatively.
Intervention
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 assess reproducibility. Healthy subjects will fill in on PRSIQ-NL questionnaire. Half of them will fill in a second PRSIQ-NL questionnaire to test reproducibility. In addition, automated refractometry will be performed in healthy subjects to assess their refractive error.
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
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
Recruitment
IPD sharing statement
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8815 |
| Other | MEC-U : Not yet appointed |