Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorEye & ENT Hospital of Fudan University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with regular corneal astigmatism of 0.75-2.0 D who plan to undergo cataract surgery. Aged between 20 and 80 years old.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
femtosecond laser-assisted arcuate keratotomy (FSAK) combined with standard cataract surgery
Procedure/Surgery1. 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
Treatment groups
105 Participants
are divided into 1 treatment groupGroup A: FSAK with Cataract Surgery1 intervention
Trial outcomes
Primary outcomes
1
Change in corneal astigmatism magnitude (diopters) from baseline
Time frame
Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperativelySecondary outcomes
1
Visual Acuity-UCVA
Uncorrected Distance Visual Acuity (UDVA) at 5m (logMAR)
Time frame
Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively2
Visual acuity-BCVA
Best-Corrected Visual Acuity (BCVA) at 5m (logMAR)
Time frame
Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively3
Manifest refraction spherical equivalent (MRSE) in Diopter (D)
Time frame
Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively4
Corneal Topography
Corneal Topography assesses corneal curvature, with data collected using the Pentacam instrument and IOL Master. The measured outcome reflects the corneal's refractive power and shape characteristics. Corneal curvature is reported in diopters (D) , a standard unit for quantifying refractive power in ophthalmic measurements.
Time frame
Preoperative; 1 week postoperatively, 1 month postoperatively, 3 months postoperatively, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperativelySponsors and contacts
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Source ClinicalTrials.gov