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

Study Overview
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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.

Official Title
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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.

Conditions
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Dry Eye, Vision Disorders, Quality of Life

Intervention / Treatment
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* Other: Diffractive multifocal IOLs group


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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: monofocal IOLs group<br>monofocal IOLs group were implantation with Tecnis® ZCB00 | Other: Diffractive multifocal IOLs group<br>* 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.<br>|
| Active Comparator: Diffractive multifocal IOLs group<br>Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00 | Other: Diffractive multifocal IOLs group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1week, 1month, 3month,6month,12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visual acuity, objective visual quality, multifocal intraocular lens, tear-film quality dynamics