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

Primary Purpose

Dry Eye, Vision Disorders, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Diffractive multifocal IOLs group
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring visual acuity, objective visual quality, multifocal intraocular lens, tear-film quality dynamics

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation.
  • Patients who could not be available for follow-up.

Sites / Locations

  • Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

monofocal IOLs group

Diffractive multifocal IOLs group

Arm Description

monofocal IOLs group were implantation with Tecnis® ZCB00

Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens
The tear-film quality dynamics including the tear break-up time and the tear-film OSI were examined by optical quality analysis system (OQAS)

Full Information

First Posted
July 31, 2014
Last Updated
September 8, 2014
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02234635
Brief Title
Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens After Cataract Surgery
Official Title
Phase 1 Evaluate the Visual Quality Change of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses; Phase 2 Evaluate the Tear Film Quality Dynamics of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Vision Disorders, Quality of Life
Keywords
visual acuity, objective visual quality, multifocal intraocular lens, tear-film quality dynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
monofocal IOLs group
Arm Type
Other
Arm Description
monofocal IOLs group were implantation with Tecnis® ZCB00
Arm Title
Diffractive multifocal IOLs group
Arm Type
Active Comparator
Arm Description
Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00
Intervention Type
Other
Intervention Name(s)
Diffractive multifocal IOLs group
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens
Description
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).
Time Frame
1week, 1month, 3month,6month,12month
Secondary Outcome Measure Information:
Title
To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens
Description
The tear-film quality dynamics including the tear break-up time and the tear-film OSI were examined by optical quality analysis system (OQAS)
Time Frame
1week, 1month, 3month,6month,12month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eyes with an axial length of 22.00 to 25.00 mm with age-related cataract. Exclusion Criteria: Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation. Patients who could not be available for follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Yu
Phone
13758452287
Email
357574103@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Yu
Organizational Affiliation
Affiliated Eye Hospital of Wenzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang, Yu
Phone
13758452287
Email
357574103@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33569446
Citation
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.
Results Reference
derived
PubMed Identifier
26903522
Citation
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.
Results Reference
derived

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

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