Visual Performance of Multifocal Intraocular Lenses

Sponsor
Wenzhou Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04913792
Collaborator
(none)
30
1
61
0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: ZXR00

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Outcomes With an Extended Range of Vision Intraocular Lens
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Jul 7, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
ZXR00

The ZXR00 group included 30 patients bilaterally implanted with the Tecnis Symfony IOL (Abbott Medical Optics, Inc.)

Device: ZXR00
This prospective comparative study included 60 eyes undergoing cataract surgery with implantation of an extended range of vision IOL.(Abbott Medical Optics, Inc.)

Outcome Measures

Primary Outcome Measures

  1. Uncorrected distance VA(5m,66cm,40cm) [After operation (Month 3)]

    logarithmic visual acuity chart

Secondary Outcome Measures

  1. Questionnaire concerning halo and visual function [After 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).

  2. abberation and kappa angle [After operation (Month 3)]

    iTrace visual function analyzer

  3. MTF cut-of and OSI [After operation (Month 3)]

    MTF cut-of and OSI values measured by optical quality analysis system [OQAS]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ophthalmology and Optometry Hospital Wenzhou Zhejiang China 325027

Sponsors and Collaborators

  • Wenzhou Medical University

Investigators

  • Study Chair: yune zhao, MD, Wenzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yune Zhao, Clinical Professor, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT04913792
Other Study ID Numbers:
  • APAC-20161013
First Posted:
Jun 4, 2021
Last Update Posted:
Jun 4, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yune Zhao, Clinical Professor, Wenzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2021