Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery

NCT07081919 | Recruiting

• 1 other identifier: FSAK during cataract surgery
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

What is this study about? This study looks at whether a laser procedure called femtosecond laser-assisted arcuate keratotomy (FSAK) helps people with both cataracts and mild astigmatism see more clearly after cataract surgery. Astigmatism causes blurry vision because the front of the eye (cornea) is curved unevenly. The FSAK procedure uses a computer-guided laser to make tiny, precise cuts in the cornea during cataract surgery to fix this curve. the investigators want to see if this improves vision long-term (up to 5 years) and what factors affect how the investigatorsll it works. Who can join? the investigators are looking for adults aged 20-80 years who: Have cataracts and mild-to-moderate astigmatism (0.75-2.0 diopters) Plan to have cataract surgery Have not had prior eye surgeries (like LASIK) Do not have severe dry eye or other eye diseases (like glaucoma or retina problems) What will happen in the study? Surgery: Participants will have cataract surgery combined with the FSAK procedure. The surgeon uses a laser to make tiny curved cuts in the cornea to reshape it. Follow-up visits: Participants will have regular eye check-ups for 5 years after surgery. These include: Vision tests (reading eye charts) Measurements of the eye's shape using painless imaging machines Questionnaires about vision quality and daily activities Time commitment: Visits happen at 1 the investigatorsek, 1 month, 3 months, 6 months, 1 year, 2 years, and 5 years after surgery. Each visit takes about 1-2 hours. Why is this study important? FSAK may help people with astigmatism see clearly after cataract surgery without needing glasses as often. By tracking results for 5 years, the investigators'll learn how long the benefits last and who benefits most. This could help doctors better personalize treatment in the future. Who is running the study? Eye doctors at Fudan University Eye \& ENT Hospital (Shanghai) and Shanghai Peace Eye Hospital. About 105 people will take part.

Conditions

Corneal Astigmatism; Cataract

Keywords

femtosecond laser-assisted arcuate keratotomy; cataract surgery; corneal astigmtism; astigmatism treatment stability; predictors of surgical outcomes

Outcome Measures

Primary Outcomes (1)

• Change in corneal astigmatism magnitude (diopters) from baseline

  Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively

Secondary Outcomes (6)

• Visual Acuity-UCVA

  Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively

• Visual acuity-BCVA

  Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively

• Manifest refraction spherical equivalent (MRSE) in Diopter (D)

  Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively

• Corneal Topography

  Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively

• Objective Optical Quality

  Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively

Study Arms (1)

FSAK with Cataract Surgery

Participants in this group undergo femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery

Procedure: femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery

Interventions

femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery PROCEDURE

1. 5-year follow-up assessing stability of astigmatism correction. Most FSAK studies track ≤2 years. This addresses critical evidence gaps in durability 2. Combines topographic data with patient-reported visual function (VF-14/QoV questionnaires at all visits. Links anatomical changes to real-world visual experiences

FSAK with Cataract Surgery

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with regular corneal astigmatism of 0.75-2.0 D who plan to undergo cataract surgery. Aged between 20 and 80 years old.

You may qualify if:

• Age: 20-80 years
• Age-related cataracts
• Regular corneal astigmatism (0.75-2.0 diopters) confirmed by Pentacam/IOLMaster 700
• Surgical Plan: Scheduled for femtosecond laser-assisted cataract surgery
• Central corneal thickness ≥500 µm
• Endothelial cell count ≥2,000 cells/mm²
• Best-corrected visual acuity (BCVA) improvable to ≥20/40

You may not qualify if:

• Prior corneal refractive surgery (e.g., LASIK, PRK)
• Intraocular surgery (e.g., glaucoma filtering surgery)
• Irregular astigmatism (keratoconus, scarring, post-traumatic distortion)
• Active ocular inflammation or infection
• Corneal endothelial disease (e.g., Fuchs' dystrophy)
• Severe dry eye (Schirmer test ≤5 mm/5 min)
• Uncontrolled glaucoma (IOP \>21 mmHg on medication)
• Macular pathology (e.g., AMD, DME affecting visual potential)
• Amblyopia
• Autoimmune diseases affecting cornea (e.g., rheumatoid arthritis, Sjögren syndrome)
• Diabetes mellitus with retinopathy
• Pregnancy/Lactation
• Inability to complete 5-year follow-up

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye and Ear, Nose, and Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Astigmatism; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Central Study Contacts

Jin Yang, PhD

CONTACT

13671632525; jin_er76@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: July 23, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 22, 2030
• Study Completion (Estimated): April 22, 2031
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)