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

Not Applicable

• Conditions: Vision Disorders; Dry Eye; Quality of Life
• Interventions: Other: Diffractive multifocal IOLs group

• Registration Number: NCT02234635
• Lead Sponsor: Wenzhou Medical University

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-07-31
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study First Submitted QC: 2014-09-08
• Last Update Submitted: 2014-09-08
• Study First Posted: 2014-09-09
• Last Update Posted: 2014-09-09
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diffractive multifocal IOLs group	Diffractive multifocal IOLs group	Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00
monofocal IOLs group	Diffractive multifocal IOLs group	monofocal IOLs group were implantation with Tecnis® ZCB00

Primary Outcome Measures

Name	Time	Method
To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens	1week, 1month, 3month,6month,12month	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

Name	Time	Method
To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens	1week, 1month, 3month,6month,12month	The tear-film quality dynamics including the tear break-up time and the tear-film OSI were examined by optical quality analysis system (OQAS)

Trial Locations

Locations (1)

Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China