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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215807
• Other study ID #: 82201158
• Secondary ID: 82201158
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yueyang Zhong
• Phone: +8618868125901
• Email: yyzbzhong[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Eye Center of the Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Keratometric astigmatism	Corneal topography measurement	1 day, 1 week, 1 month, 3 months and 1year postoperatively
Primary	Refractive astigmatism	subjective manifest refraction and residual astigmatism	1 day, 1 week, 1 month, 3 months and 1year postoperatively
Secondary	Visual acuity	uncorrected distance visual acuity and corrected distance visual acuity	1 day, 1 week, 1 month, 3 months and 1year postoperatively