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

• Conditions: cataract

• Registration Number: NL-OMON21890
• Lead Sponsor: Relationship between spectacle dependency, as assessed with PRSIQ-NL, and visual functioning, as assessed with Catquest-9SF-NL, after cataract surgery.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 400

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

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