Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery
Eye & ENT Hospital of Fudan University
105 participants
Apr 22, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria13
- 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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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07081919