NCT06215807

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

January 11, 2024

Last Update Submit

January 11, 2024

Conditions

CataractAstigmatism

Keywords

Astigmatism correctionFemtosecond laser arcuate keratotomyToric intraocular lens implantationFemtosecond laser-assisted cataract surgery

Outcome Measures

Primary Outcomes (1)

  • Refractive astigmatism

    subjective manifest refraction and residual astigmatism

    1 day, 1 week, 1 month, 3 months and 1year postoperatively

Secondary Outcomes (1)

  • Visual acuity

    1 day, 1 week, 1 month, 3 months and 1year postoperatively

Other Outcomes (1)

  • Keratometric astigmatism

    1 day, 1 week, 1 month, 3 months and 1year postoperatively

Study Arms (2)

Femtosecond laser arcuate keratotomy

ACTIVE COMPARATOR

femtosecond laser arcuate keratotomy will be designed using Donnenfeld nomogram.

Procedure: Femtosecond laser arcuate keratotomy

Toric intraocular lens implantation

ACTIVE COMPARATOR

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

Procedure: Toric intraocular lens implantation

Interventions

Femtosecond laser arcuate keratotomyPROCEDURE

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

Femtosecond laser arcuate keratotomy
Toric intraocular lens implantationPROCEDURE

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

Toric intraocular lens implantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33795782BACKGROUND

  • 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.

    PMID: 26352561BACKGROUND

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Ke Yao

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY CHAIR

Central Study Contacts

Yueyang Zhong

CONTACT

+8618868125901yyzbzhong@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 22, 2024

Study Start

October 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

CN(1)