Skip to content

Visual Performance of Multifocal Intraocular Lenses

Clinical Outcomes With an Extended Range of Vision Intraocular Lens

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04913792
Enrollment
30
Registered
2021-06-04
Start date
2016-11-01
Completion date
2021-12-01
Last updated
2021-06-04

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

Conditions

Cataract, IOL

Keywords

multifocal IOL, ocular optical quality, abberation

Brief summary

To evaluate the clinical outcomes with an extended range of vision (ERV) IOL based on achromatic diffractive technology.

Detailed description

This was a prospective comparative study including 60 eyes undergoing cataract surgery with implantation of the ERV Tecnis Symfony IOL (Abbott Medical Optics, Inc.) (ERV group: 60 eyes of 30 patients). Visual, refractive, contrast sensitivity, defocus curve, ocular optical quality (Optical Quality Analysis System; iTrace), and visual function questionair(NEI-VFQ 25) outcomes were evaluated during a 3-month follow-up.

Interventions

DEVICEZXR00

This prospective comparative study included 60 eyes undergoing cataract surgery with implantation of an extended range of vision IOL.(Abbott Medical Optics, Inc.)

Sponsors

Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* visually significant cataract * age of 20 years or older * preoperative corneal astigmatism of 1.50 diopters (D) or lower.

Exclusion criteria

* previous ocular surgery * active ocular pathology * amblyopia * systemic or ocular medication that could affect vision * subclinical or clinical corneal ectatic disease * pupil abnormalities * intraoperative complication leading to capsular or zonular abnormalities

Design outcomes

Primary

MeasureTime frameDescription
Uncorrected distance VA(5m,66cm,40cm)After operation (Month 3)logarithmic visual acuity chart

Secondary

MeasureTime frameDescription
Questionnaire concerning halo and visual functionAfter operation (Month 3)NEI-VFQ 25 patient questionnaire score. The questionnaire consisted of 3 parts. The first part assessed patients' satisfaction with their overall vision during the day, or at night. The score ranged from 1 to 5 (1 = not at all; 2 = a little bit; 3 = moderately; 4 = quite a bit; 5 = extremely). In part 2, patients were asked to rate the extent to which they have difficulties with their overall vision during the day or at night. The score ranged from 1 to 5 (1 = none of the time; 2 = some of the time; 3 = half of the time; 4 = most of the time; 5 = all of the time). In part 3, patients were asked to rate their overall vision and their vision at near, intermediate, and distance on a scale ranging from 0 to 10 (0 = worst; 10 = best).
abberation and kappa angleAfter operation (Month 3)iTrace visual function analyzer
MTF cut-of and OSIAfter operation (Month 3)MTF cut-of and OSI values measured by optical quality analysis system \[OQAS\]

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026