Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens After Cataract Surgery

NCT ID: NCT02234635

Last Updated: 2014-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-02-28

Brief Summary

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In this study, the investigators examined the subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS value (OV),and the tear-film quality dynamics including the tear break-up time and the tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality analysis system (OQAS).

Detailed Description

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50 eyes of 50 cataract patients scheduled for phacoemulsification surgery were recruited, the multifocal group (25 eyes) ,were implantation with Tecnis® ZMB00;and the monofocal group (25 eyes) were implantation with Tecnis® ZCB00.

Methods: All eyes were examined by logMAR visual acuity chart and Optical quality analysis system (OQAS) at 1 week, 1 month, 3 month, 6 month,12 month after surgery for the subjective and objective visual quality Change during the first year.

Measures:Subjective and objective visual quality were evaluated.Tear-film quality dynamicswere evaluated.

Conditions

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Dry Eye Vision Disorders Quality of Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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monofocal IOLs group

monofocal IOLs group were implantation with Tecnis® ZCB00

Group Type OTHER

Diffractive multifocal IOLs group

Intervention Type OTHER

Diffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity.

Diffractive multifocal IOLs group

Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00

Group Type ACTIVE_COMPARATOR

Diffractive multifocal IOLs group

Intervention Type OTHER

Diffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity.

Interventions

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Diffractive multifocal IOLs group

Diffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Eyes with an axial length of 22.00 to 25.00 mm with age-related cataract.

Exclusion Criteria

* Patients who could not be available for follow-up.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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yin ying zhao

doctor of ophthalmology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang Yu

Role: STUDY_DIRECTOR

Affiliated Eye Hospital of Wenzhou Medical University

Locations

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Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Yu

Role: CONTACT

13758452287

Facility Contacts

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Fang, Yu

Role: primary

13758452287

References

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Ye L, Chen T, Hu Z, Yang Q, Su Q, Li J. Comparison of the visual performance between Oculentis MF30 and Tecnis ZMB00 multifocal intraocular lenses. Ann Transl Med. 2021 Jan;9(2):144. doi: 10.21037/atm-20-7777.

Reference Type DERIVED
PMID: 33569446 (View on PubMed)

Chen T, Yu F, Lin H, Zhao Y, Chang P, Lin L, Chen Q, Zheng Q, Zhao YE, Lu F, Li J. Objective and subjective visual quality after implantation of all optic zone diffractive multifocal intraocular lenses: a prospective, case-control observational study. Br J Ophthalmol. 2016 Nov;100(11):1530-1535. doi: 10.1136/bjophthalmol-2015-307135. Epub 2016 Feb 22.

Reference Type DERIVED
PMID: 26903522 (View on PubMed)

Other Identifiers

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VQIOL-21

Identifier Type: -

Identifier Source: org_study_id

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