Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs (NCT07453992) | Clinical Trial Compass
RecruitingNot Applicable
Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs
China400 participantsStarted 2025-01-01
Plain-language summary
This prospective comparative cohort study evaluates and compares postoperative rotational stability and time-course dynamics of three commercially available toric intraocular lenses (TECNIS Toric II \[ZCU\], AcrySof IQ Toric, and AT TORBI 709M) after phacoemulsification cataract surgery. Rotation is quantified by registering postoperative retroillumination photographs to the end-of-surgery baseline using iris/scleral landmarks, with follow-up at postoperative day 1, day 3, week 1, week 2, month 1, and month 3. Associations between rotational outcomes and ocular biometric parameters are analyzed using linear mixed-effects models to inform individualized IOL selection and perioperative management.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees
Timeframe: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.