Registry Study on Hydrophilic (HydroSmart) and Hydrophobic (ACUNEX) Intraocular Lenses Manufactured by Teleon Surgical B.V.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,183
- Locations
- 1
- Primary Endpoint
- Visual acuity (uncorrected and/or corrected)
Study Overview
Brief Summary
This is a retrospective, observational (Registry) study aiming to collect safety and performance data on the use of intraocular lenses (IOLs) manufactured by Teleon Surgical B.V. according to routine practice.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients older than 18 years
- •Diagnosis of cataract in at least one eye or seeking clear/refractive lens exchange
- •Provide consent to retrospective data collection
Exclusion Criteria
- •Patients younger than 18 years
- •Patients with congenital primary aphakia or secondary aphakia
Outcomes
Primary Outcomes
Visual acuity (uncorrected and/or corrected)
Time Frame: Preoperatively to Month 24
Monocular visual acuity measured under photopic conditions from preoperative to Month 24 using standard methods (e.g. Snellen Chart 6/6-metre, 1.0 decimal or 0.0 logMAR) at standard distances (4 m for far, 65-80 cm for intermediate and 35-40 cm for near distance), depending on IOL optical design, as follows: For monofocal IOLs: • Uncorrected and corrected distance visual acuity For monofocal toric IOLs: * Uncorrected and corrected distance visual acuity * Residual astigmatism * IOL rotation For multifocal IOLs: * Uncorrected and corrected distance visual acuity * Uncorrected and corrected near visual acuity * Uncorrected and corrected intermediate visual acuity, if available For multifocal toric IOLs: * Uncorrected and corrected distance visual acuity * Uncorrected and corrected near visual acuity * Uncorrected and corrected intermediate visual acuity, if available * Residual astigmatism * IOL rotation
Secondary Outcomes
- Adverse events and adverse device effects(Usual follow-up: 24 Months)
- Patient and user satisfaction(Month 1)