How three toric intraocular lenses rotate after cataract surgery
Postoperative Rotational Dynamics of Different Toric Intraocular Lens Designs
This study tests how well three commercial toric intraocular lenses hold their orientation over the first three months after cataract surgery in adults with corneal astigmatism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07453992 on ClinicalTrials.gov |
What this trial studies
This is a prospective comparative cohort study enrolling adults having phacoemulsification with implantation of one of three commercially available toric intraocular lenses (TECNIS Toric II ZCU, AcrySof IQ Toric, AT TORBI 709M). Postoperative lens rotation is measured by registering retroillumination photographs to an end-of-surgery baseline using iris and scleral landmarks. Patients are followed on postoperative day 1, day 3, week 1, week 2, month 1, and month 3 to define the time course of rotational changes. Associations between rotational outcomes and ocular biometric parameters are analyzed using linear mixed-effects models to inform individualized lens selection and perioperative management.
Who should consider this trial
Good fit: Adults aged 18 or older with age-related cataract and regular corneal astigmatism who are candidates for implantation of one of the three study toric intraocular lenses.
Not a fit: Patients with prior ocular surgery, irregular corneal astigmatism, zonular weakness, active ocular inflammation or other conditions that affect biometric reliability or surgery outcome are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the results could help surgeons choose toric lenses that are less likely to rotate, improving visual outcomes and reducing the need for reintervention.
How similar studies have performed: Previous research has shown variable rotational stability across different toric lens models with some lenses demonstrating better stability, but direct, detailed three-way time-course comparisons are relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older with age-related cataract scheduled for phacoemulsification cataract surgery. * Presence of regular corneal astigmatism requiring toric intraocular lens implantation. * Eligible for implantation of one of the three study toric intraocular lenses based on preoperative evaluation. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: * History of prior ocular surgery in the study eye. * History of ocular trauma in the study eye. * Irregular corneal astigmatism or corneal pathology affecting reliable biometric measurement. * Intraoperative complications, including anterior capsular tear or posterior capsular rupture. * Inadequate pupillary dilation during surgery or postoperative examinations. * Evidence of zonular weakness, zonular dialysis, or lens subluxation. * Active ocular infection or inflammation. * Any other ocular or systemic condition judged by the investigator to potentially affect intraocular lens stability or study outcomes.
Where this trial is running
Shanghai, Shanghai Municipality
- Eye and ENT hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jin Yang — Fudan University
- Study coordinator: Xuanqiao Lin
- Email: 1532483480@qq.com
- Phone: +8615088920668
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.