NCT02234635

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

2.1 years

First QC Date

July 31, 2014

Last Update Submit

September 8, 2014

Conditions

Dry EyeVision DisordersQuality of Life

Keywords

visual acuityobjective visual qualitymultifocal intraocular lenstear-film quality dynamics

Outcome Measures

Primary Outcomes (1)

  • To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens

    Visual quality change during the first year after cataract surgery. The visual quality including the subjective and objective visual quality. 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) and distance corrected near visual acuity (DCNVA). The objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI) and OQAS value (OV).

    1week, 1month, 3month,6month,12month

Secondary Outcomes (1)

  • To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens

    1week, 1month, 3month,6month,12month

Study Arms (2)

monofocal IOLs group

OTHER

monofocal IOLs group were implantation with Tecnis® ZCB00

Other: Diffractive multifocal IOLs group

Diffractive multifocal IOLs group

ACTIVE COMPARATOR

Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00

Other: Diffractive multifocal IOLs group

Interventions

Diffractive multifocal IOLs groupOTHER

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 groupmonofocal IOLs group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who could not be available for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33569446DERIVED

  • 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.

    PMID: 26903522DERIVED

MeSH Terms

Conditions

Dry Eye SyndromesVision Disorders

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fang Yu

    Affiliated Eye Hospital of Wenzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

Fang Yu

CONTACT

13758452287357574103@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor of ophthalmology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

July 31, 2014

First Posted

September 9, 2014

Study Start

August 1, 2012

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

CN(1)