Visual Performance of Multifocal Intraocular Lenses

• Conditions: IOL; Cataract
• Interventions: Device: ZXR00

• Registration Number: NCT04913792
• Lead Sponsor: Wenzhou Medical University

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.

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-11-06
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-30
• Last Update Submitted: 2021-05-30
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Primary Completion: 2021-07-07
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Uncorrected distance VA（5m，66cm，40cm）	After operation （Month 3）	logarithmic visual acuity chart

Secondary Outcome Measures

Name	Time	Method
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).
abberation and kappa angle	After operation （Month 3）	iTrace visual function analyzer
MTF cut-of and OSI	After operation （Month 3）	MTF cut-of and OSI values measured by optical quality analysis system \[OQAS\]

Trial Locations

Locations (1)

Ophthalmology and Optometry Hospital; 🇨🇳 Wenzhou, Zhejiang, China