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

Zhejiang University

Status: Enrolling

Conditions: Cataract; Astigmatism

Treatments: Procedure: Femtosecond laser arcuate keratotomy; Procedure: Toric intraocular lens implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06215807

82201158 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Femtosecond laser arcuate keratotomy

Active Comparator group

Description:

femtosecond laser arcuate keratotomy will be designed using Donnenfeld nomogram.

Treatment:

Procedure: Femtosecond laser arcuate keratotomy

Toric intraocular lens implantation

Active Comparator group

Description:

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

Treatment:

Procedure: Toric intraocular lens implantation