NCT07081919 Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery
| NCT ID | NCT07081919 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Corneal Astigmatism |
| Study Type | OBSERVATIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2030-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 105 participants in total. It began in 2025-04-22 with a primary completion date of 2030-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07081919 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Corneal Astigmatism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07081919 currently recruiting?
Yes, NCT07081919 is actively recruiting participants. Contact the research team at jin_er76@hotmail.com for enrollment information.
Where is the NCT07081919 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07081919 clinical trial?
NCT07081919 is sponsored by Eye & ENT Hospital of Fudan University. The trial plans to enroll 105 participants.