Femtosecond laser arcuate keratotomy to reduce corneal astigmatism during cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with age-related cataract and regular corneal astigmatism (0.75–2.0 D) who undergo femtosecond laser-assisted arcuate keratotomy at the time of cataract extraction. Investigators will collect refractive measures, corneal topography/tomography, visual acuity, and endothelial and intraocular pressure data before surgery and at multiple visits up to 5 years postoperatively. The aim is to document how much astigmatism is reduced, how stable that correction is over time, and which preoperative eye characteristics predict better or worse outcomes. Visits include early checks (1 week, 1 month), intermediate (3 and 6 months), and long-term follow-up (1, 2, and 5 years).

Why it matters

Who can join: the full rules

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

Where it's running

• Eye and Ear, Nose, and Throat Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jin Yang, PhD
• Email: jin_er76@hotmail.com
• Phone: 13671632525

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.