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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Astigmatism
• Intervention / Treatment: Procedure: Femtosecond laser arcuate keratotomy; Procedure: Toric intraocular lens implantation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueyang Zhong; Phone Number: +8618868125901; Email: yyzbzhong@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Eye Center of the Second Affiliated Hospital of Zhejiang University
      • Contact: Yueyang Zhong; Phone Number: +8618868125901; Email: yyzbzhong@zju.edu.cn
      • Principal Investigator: Yueyang Zhong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femtosecond laser arcuate keratotomy; femtosecond laser arcuate keratotomy will be designed using Donnenfeld nomogram.	Procedure: 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.
Active Comparator: Toric intraocular lens implantation; The Toric IOL power and alignment axis were calculated using the online calculator available at https://www.tecnistoriccalc.com	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive astigmatism	subjective manifest refraction and residual astigmatism	1 day, 1 week, 1 month, 3 months and 1year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	uncorrected distance visual acuity and corrected distance visual acuity	1 day, 1 week, 1 month, 3 months and 1year postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratometric astigmatism	Corneal topography measurement	1 day, 1 week, 1 month, 3 months and 1year postoperatively

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Ke Yao, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Astigmatism correction; Femtosecond laser arcuate keratotomy; Toric intraocular lens implantation; Femtosecond laser-assisted cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: 82201158 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No