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

NCT07081919 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2025-07-23

No results posted yet for this study

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

Interventions

PROCEDURE

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

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

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2030-04-22
Completion
2031-04-22

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081919 on ClinicalTrials.gov