Actively Recruiting
Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-07-23
105
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 80 years
- Diagnosed with age-related cataracts
- Regular corneal astigmatism between 0.75 and 2.0 diopters confirmed by Pentacam or IOLMaster 700
- Scheduled for femtosecond laser-assisted cataract surgery
- Central corneal thickness of at least 500 micrometers
- Endothelial cell count of at least 2,000 cells/mm²
- Best-corrected visual acuity that can improve to 20/40 or better
You will not qualify if you...
- Previous corneal refractive surgery such as LASIK or PRK
- Prior intraocular surgeries like glaucoma filtering surgery
- Irregular astigmatism caused by keratoconus, scarring, or trauma
- Active eye inflammation or infection
- Corneal endothelial diseases like Fuchs' dystrophy
- Severe dry eye with Schirmer test 5 mm or less in 5 minutes
- Uncontrolled glaucoma with intraocular pressure over 21 mmHg despite medication
- Macular diseases such as age-related macular degeneration or diabetic macular edema
- Amblyopia
- Autoimmune diseases affecting the cornea like rheumatoid arthritis or Sjögren syndrome
- Diabetes with retinopathy
- Pregnancy or breastfeeding
- Unable to commit to 5-year follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Eye and Ear, Nose, and Throat Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
Research Team
J
Jin Yang, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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