Femtosecond Laser Arcuate Keratotomy Versus Toric Intraocular Lens Implantation in Cataract Surgery

NCT ID: NCT06215807

Last Updated: 2024-01-22

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-01-31

Brief Summary

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In modern cataract surgery, residual astigmatism continues to be one of the major factors influencing patients' visual quality and satisfaction. The goal of this study is to compare the clinical outcomes of femtosecond laser arcuate keratotomy in one eye and Toric intraocular lens implantation in the contralateral eye for astigmatism correction in patients undergoing femtosecond laser-assisted cataract surgery. The study is a prospective randomized comparative study. Patients with binocular regular corneal astigmatism ranging from 0.75 to 3.00 D will be recruited. The patient will randomly receive femtosecond laser arcuate keratotomy in one eye and receive Toric intraocular lens implantation in the contralateral eye. Long term evaluation will be performed to compare the visual acuity, subjective manifest refraction, and corneal topography between groups.

Detailed Description

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Conditions

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Cataract Astigmatism

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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Femtosecond laser arcuate keratotomy

femtosecond laser arcuate keratotomy will be designed using Donnenfeld nomogram.

Group Type ACTIVE_COMPARATOR

Femtosecond laser arcuate keratotomy

Intervention Type PROCEDURE

The patient will receive femtosecond laser arcuate keratotomy and femtosecond laser-assisted cataract surgery with implantation of a monofocal intraocular lens in one eye.

Toric intraocular lens implantation

The Toric IOL power and alignment axis were calculated using the online calculator available at https://www.tecnistoriccalc.com

Group Type ACTIVE_COMPARATOR

Toric intraocular lens implantation

Intervention Type PROCEDURE

The patient will receive femtosecond laser-assisted cataract surgery with implantation of a Toric monofocal intraocular lens in the contralateral eye.

Interventions

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Femtosecond laser arcuate keratotomy

The patient will receive femtosecond laser arcuate keratotomy and femtosecond laser-assisted cataract surgery with implantation of a monofocal intraocular lens in one eye.

Intervention Type PROCEDURE

Toric intraocular lens implantation

The patient will receive femtosecond laser-assisted cataract surgery with implantation of a Toric monofocal intraocular lens in the contralateral eye.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* cataract patients
* patients with binocular regular corneal astigmatism ranging from 0.75 to 3.00 D
* 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

18 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

Principal Investigators

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Ke Yao

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Role: CONTACT

+8618868125901

Facility Contacts

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Yueyang Zhong

Role: primary

+8618868125901

References

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Noh H, Yoo YS, Shin KY, Lim DH, Chung TY. Comparison of penetrating femtosecond laser-assisted astigmatic keratotomy and toric intraocular lens implantation for correction of astigmatism in cataract surgery. Sci Rep. 2021 Apr 1;11(1):7340. doi: 10.1038/s41598-021-86763-5.

Reference Type BACKGROUND
PMID: 33795782 (View on PubMed)

Yoo A, Yun S, Kim JY, Kim MJ, Tchah H. Femtosecond Laser-assisted Arcuate Keratotomy Versus Toric IOL Implantation for Correcting Astigmatism. J Refract Surg. 2015 Sep;31(9):574-8. doi: 10.3928/1081597X-20150820-01.

Reference Type BACKGROUND
PMID: 26352561 (View on PubMed)

Other Identifiers

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82201158

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

82201158

Identifier Type: -

Identifier Source: org_study_id

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