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

Sponsor

Wenzhou Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02234635

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Vision Disorders Quality of Life	Other: Diffractive multifocal IOLs group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: monofocal IOLs group monofocal IOLs group were implantation with Tecnis® ZCB00	Other: 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.
Active Comparator: Diffractive multifocal IOLs group Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00	Other: 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.

Arm

Intervention/Treatment

Other: monofocal IOLs group

monofocal IOLs group were implantation with Tecnis® ZCB00

Other: 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.

Active Comparator: Diffractive multifocal IOLs group

Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00

Other: Diffractive multifocal IOLs group

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wenzhou Medical University	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

Wenzhou Medical University

Investigators

Study Director: Fang Yu, Affiliated Eye Hospital of Wenzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

yin ying zhao, doctor of ophthalmology, Principal Investigator, Clinical Professor, Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT02234635

Other Study ID Numbers:

VQIOL-21

First Posted:

Sep 9, 2014

Last Update Posted:

Sep 9, 2014

Last Verified:

Sep 1, 2014

Keywords provided by yin ying zhao, doctor of ophthalmology, Principal Investigator, Clinical Professor, Wenzhou Medical University

visual acuity

objective visual quality

multifocal intraocular lens

tear-film quality dynamics

Additional relevant MeSH terms:

Vision Disorders

Study Results

No Results Posted as of Sep 9, 2014