Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
Location status: Recruiting
Recruiting
NCT Number: NCT07453992
Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
TECNIS Toric II (ZCU)
DeviceUsing TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.
AcrySof IQ Toric
DeviceUsing AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.
AT TORBI 709M
DeviceUsing the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.
Primary outcomes
-
Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees
Time frame: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.
Absolute rotation of the implanted toric intraocular lens (IOL) relative to the intended axis, measured in degrees. Rotation will be quantified by registering postoperative retroillumination images to the end-of-surgery baseline frame using iris or scleral landmarks. The absolute rotation angle will be calculated for each follow-up visit.
Secondary outcomes
-
Uncorrected and corrected distance visual acuity (UDVA and CDVA)
Time frame: postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months
Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) measured using a standardized logarithm of the minimum angle of resolution (logMAR) visual acuity chart during follow-up.
-
Postoperative residual refractive astigmatism measured in diopters
Time frame: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.
Residual refractive astigmatism measured by manifest refraction during follow-up visits and reported in diopters (D).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Jin Yang
Other
Registry information
Official study title
Postoperative Rotational Dynamics of Different Toric Intraocular Lens Designs
Acronym: 3 TORIC ROTATE
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2030
- First posted
- Mar 6, 2026
- Registry last updated
- Mar 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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