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Search / Trial NCT07081919

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

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Jul 21, 2025

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Femtosecond Laser Assisted Arcuate Keratotomy Cataract Surgery Corneal Astigmtism Astigmatism Treatment Stability Predictors Of Surgical Outcomes

ClinConnect Summary

This study is testing whether a special laser technique called femtosecond laser-assisted arcuate keratotomy (FSAK) can help people who have both cataracts and mild astigmatism see more clearly after cataract surgery. Astigmatism happens when the front of the eye, called the cornea, is shaped unevenly, causing blurry vision. During cataract surgery, this laser makes tiny, precise cuts in the cornea to gently reshape it and reduce astigmatism. The study will follow patients for up to five years to see how well this treatment works over time and what factors might affect the results.

Adults between 20 and 80 years old who have cataracts and mild-to-moderate astigmatism (measured as 0.75 to 2.0 diopters), and who are planning to have cataract surgery, may be able to join. People who have had previous eye surgeries, severe dry eye, or other serious eye problems won’t be eligible. Participants will have the combined laser and cataract surgery, then return for regular check-ups over five years to measure their vision, eye shape, and how their eyesight affects daily life. Each visit will take about 1-2 hours. This study is important because it could help more people reduce their need for glasses after cataract surgery and help doctors personalize treatment plans in the future.

Gender

ALL

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

About Eye & Ent Hospital Of Fudan University

The Eye & ENT Hospital of Fudan University is a leading clinical research institution dedicated to advancing the fields of ophthalmology and otolaryngology. With a commitment to innovative medical practices and patient-centered care, the hospital integrates cutting-edge research with clinical expertise to conduct comprehensive clinical trials. Leveraging a multidisciplinary approach, the institution aims to enhance treatment modalities and improve patient outcomes through rigorous scientific investigation and collaboration with academic and industry partners. Its state-of-the-art facilities and experienced team of professionals position the Eye & ENT Hospital of Fudan University as a pivotal contributor to medical advancements in eye and ear, nose, and throat health.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported