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Recruiting NCT07453992

Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs

No phase Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TECNIS Toric II (ZCU), AcrySof IQ Toric, AT TORBI 709M.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Postoperative Rotational Dynamics of Different Toric Intraocular Lens Designs

Overview

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.

Interventions

  • Device TECNIS Toric II (ZCU)
    Using TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.
  • Device AcrySof IQ Toric
    Using AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.
  • Device AT TORBI 709M
    Using the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.

Primary outcome measures

  • 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.]
Secondary outcome measures (2)
  • 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]
  • Postoperative residual refractive astigmatism measured in diopters [Time frame: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Eye and ENT hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07453992 · Totic-2026-001 · 82171039

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗