Clinical trial NCT06215807: Femtosecond Laser Arcuate Keratotomy Versus Toric Intraocular Lens Implantation in Cataract Surgery
Official title: Femtosecond Laser Arcuate Keratotomy Versus Toric Intraocular Lens Implantation in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Astigmatism
Keywords: Astigmatism correction
Femtosecond laser arcuate keratotomy
Toric intraocular lens implantation
Femtosecond laser-assisted cataract surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Refractive astigmatism
timeFrame: 1 day, 1 week, 1 month, 3 months and 1year postoperatively
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 day, 1 week, 1 month, 3 months and 1year postoperatively
Other outcomes:
measure: Keratometric astigmatism
timeFrame: 1 day, 1 week, 1 month, 3 months and 1year postoperatively
Locations:
city: Hangzhou
country: China
facility: Eye Center of the Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Ke Yao
role: STUDY_CHAIR
References:
citation: 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.
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.