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

Recruitingn/aAges 20 Years - 80 YearsAllEye & ENT Hospital of Fudan University
NCT07081919 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria * 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 Exclusion Criteria * 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
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What it tests

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

1 site
Eye and Ear, Nose, and Throat Hospital of Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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