Femtosecond laser arcuate keratotomy to reduce corneal astigmatism during cataract surgery
Effectiveness, Stability and Influence Factors of Femtosecond Laser Assisted Cataract Surgery
This study will try using a computer-guided femtosecond laser cut (FSAK) during cataract surgery to reduce mild-to-moderate corneal astigmatism in adults aged 20–80.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07081919 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates are adults 20–80 with age-related cataract, regular corneal astigmatism between 0.75 and 2.0 diopters, scheduled for femtosecond laser-assisted cataract surgery, with adequate corneal thickness and endothelial cell count and no prior corneal refractive or intraocular surgery.
Not a fit: Patients with irregular astigmatism, prior refractive or intraocular surgery, severe dry eye, corneal endothelial disease, uncontrolled glaucoma, macular pathology, or astigmatism outside the 0.75–2.0 D range are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the procedure could lower residual astigmatism after cataract surgery and reduce dependence on glasses for many patients.
How similar studies have performed: Previous short-term studies have shown that FSAK can reduce low-to-moderate astigmatism, but long-term (multi-year) stability and clear predictors of success remain less well documented.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.