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

Not Applicable

Recruiting

• Conditions: Cataract; Astigmatism
• Interventions: Procedure: Toric intraocular lens implantation; Procedure: Femtosecond laser arcuate keratotomy

• Registration Number: NCT06215807
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Refractive astigmatism	1 day, 1 week, 1 month, 3 months and 1year postoperatively	subjective manifest refraction and residual astigmatism

Secondary Outcome Measures

Name	Time	Method
Visual acuity	1 day, 1 week, 1 month, 3 months and 1year postoperatively	uncorrected distance visual acuity and corrected distance visual acuity

Trial Locations

Locations (1)

Eye Center of the Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China