Visual Performance of Multifocal Intraocular Lenses

Wenzhou Medical University30 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

IOL Cataract

Interventions

ZXR00DEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, China

Outcomes

Primary Outcomes

Uncorrected distance VA（5m，66cm，40cm）

logarithmic visual acuity chart

Time frame: After operation （Month 3）

Secondary Outcomes

Questionnaire concerning halo and visual function

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).

Time frame: After operation （Month 3）

abberation and kappa angle

iTrace visual function analyzer

Time frame: After operation （Month 3）

MTF cut-of and OSI

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

Time frame: After operation （Month 3）

Data from ClinicalTrials.gov

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