Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs (3 TORIC ROTATE)

March 5, 2026 updated by: Jin Yang

Postoperative Rotational Dynamics of Different 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Eye and ENT Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TECNIS Toric II (ZCU)
Participants randomized to this arm receive implantation of the TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.
Device: TECNIS Toric II (ZCU)
Using TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.
Active Comparator: AcrySof IQ Toric
Participants randomized to this arm receive implantation of the AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.
Device: AcrySof IQ Toric
Using AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.
Active Comparator: AT TORBI 709M
Participants randomized to this arm receive implantation of the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.
Device: AT TORBI 709M
Using the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months
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).
Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jin Yang

Investigators

  • Principal Investigator: Jin Yang, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Totic-2026-001
  • 82171039 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on TECNIS Toric II (ZCU)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe