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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06215807
Enrollment
200
Registered
2024-01-22
Start date
2023-10-01
Completion date
2026-01-31
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Cataract

Keywords

Astigmatism correction, Femtosecond laser arcuate keratotomy, Toric intraocular lens implantation, Femtosecond laser-assisted cataract surgery

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.

Interventions

PROCEDUREFemtosecond 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.

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Refractive astigmatism1 day, 1 week, 1 month, 3 months and 1year postoperativelysubjective manifest refraction and residual astigmatism

Secondary

MeasureTime frameDescription
Visual acuity1 day, 1 week, 1 month, 3 months and 1year postoperativelyuncorrected distance visual acuity and corrected distance visual acuity

Other

MeasureTime frameDescription
Keratometric astigmatism1 day, 1 week, 1 month, 3 months and 1year postoperativelyCorneal topography measurement

Countries

China

Contacts

Primary ContactYueyang Zhong
yyzbzhong@zju.edu.cn+8618868125901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026