Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery: a Randomized Controlled Trial

NCT ID: NCT06658119

Last Updated: 2025-03-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2026-03-01

Brief Summary

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The goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tecnis Synergy ZFR00 IOL

Tecnis Synergy ZFR00 IOL will be implanted in the patient's eye during cataract surgery.

Group Type EXPERIMENTAL

cataract surgery

Intervention Type PROCEDURE

The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Synergy ZFR00).

Tecnis Symfony ZXR00 IOL

Tecnis Symfony ZXR00 IOL will be implanted in the patient's eye during cataract surgery.

Group Type PLACEBO_COMPARATOR

cataract surgery

Intervention Type PROCEDURE

The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Symfony ZXR00).

Interventions

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cataract surgery

The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Synergy ZFR00).

Intervention Type PROCEDURE

cataract surgery

The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Symfony ZXR00).

Intervention Type PROCEDURE

Other Intervention Names

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intraocular lens implantation intraocular lens implantation

Eligibility Criteria

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Inclusion Criteria

* age-related cataract patients aged between 40 to 80
* patients with preoperative astigmatism less than 0.75 D, and kappa value less than 0.7 mm
* patients who plan to receive femtosecond laser-assisted cataract surgery

Exclusion Criteria

* patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
* patients with history of ocular trauma or surgery
* patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
* patients with concurrent severe systemic diseases
* patients who lack of cooperation
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yueyang Zhong, MD.

Role: CONTACT

+8618868125901

Facility Contacts

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Yueyang Zhong

Role: primary

18868125901

Other Identifiers

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20241068

Identifier Type: -

Identifier Source: org_study_id

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