Comparison on Outcomes of Four IOLs in Patients With Cataracts

NCT ID: NCT06590272

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-06-30

Brief Summary

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The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into 4 groups. Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.

Detailed Description

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The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into group A (TECNIS PCB00 IOL), Group B (HumanOptics Diff-Aay IOL), Group C (TECNIS Symfony ZXR00 IOL) and group D (ZEISS AT LISA tri 839MP IOL). Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.

Conditions

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Cataract Intraocular Lens Visual Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TECNIS PCB00 IOL (A)

The patients in this groups underwent cataract surgery with TECNIS PCB00 IOL

TECNIS PCB00 intraocular lens

Intervention Type DEVICE

In this study, we select TECNIS PCB00 IOL for inserting in the eyes during the cataract surgery

HumanOptics Diff-Aay IOL (B)

The patients in this groups underwent cataract surgery with HumanOptics Diff-Aay IOL

HumanOptics Diff-Aay intraocular lens

Intervention Type DEVICE

In this study, we select HumanOptics Diff-Aay IOL for inserting in the eyes during the cataract surgery

TECNIS Symfony ZXR00 IOL (C)

The patients in this groups underwent cataract surgery with TECNIS Symfony ZXR00 IOL

TECNIS Symfony ZXR00 intraocular len

Intervention Type DEVICE

In this study, we select TECNIS Symfony ZXR00 IOL for inserting in the eyes during the cataract surgery

ZEISS AT LISA tri 839MP IOL (D)

The patients in this groups underwent cataract surgery with ZEISS AT LISA tri 839MP IOL

ZEISS AT LISA tri 839MP intraocular len

Intervention Type DEVICE

In this study, we select ZEISS AT LISA tri 839MP IOL for inserting in the eyes during the cataract surgery

Interventions

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TECNIS PCB00 intraocular lens

In this study, we select TECNIS PCB00 IOL for inserting in the eyes during the cataract surgery

Intervention Type DEVICE

HumanOptics Diff-Aay intraocular lens

In this study, we select HumanOptics Diff-Aay IOL for inserting in the eyes during the cataract surgery

Intervention Type DEVICE

TECNIS Symfony ZXR00 intraocular len

In this study, we select TECNIS Symfony ZXR00 IOL for inserting in the eyes during the cataract surgery

Intervention Type DEVICE

ZEISS AT LISA tri 839MP intraocular len

In this study, we select ZEISS AT LISA tri 839MP IOL for inserting in the eyes during the cataract surgery

Intervention Type DEVICE

Other Intervention Names

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IOL IOL IOL IOL

Eligibility Criteria

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Inclusion Criteria

* age-related cataract with myopia≤-6.0D and over 0.0D
* axial length≤26mm and corneal astigmatism≤1.5D
* well-cooperation of finishing preoperative examinations
* completion of all follow-up visits

Exclusion Criteria

* previous eye diseases that affect vision including keratopathy, glaucoma, uveitis, amblyopia, fundus diseases, etc.
* patients with decreased cognitive ability, unable to cooperate with preoperative examination, or suffering from severe anxiety, depression and mental illness
* serious complications during operation, including corneal injury, iris injury, expelling choroidal hemorrhage, posterior capsule rupture, etc
* serious postoperative complications, including displacement of intraocular lens, macular edema, endophthalmitis, etc
* follow-ups less than 3months
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sun Yilin

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yiwen Hu

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHSY-LYZX-210

Identifier Type: -

Identifier Source: org_study_id

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