RecruitingNot ApplicableNCT07453992

Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs

Postoperative Rotational Dynamics of Different Toric Intraocular Lens Designs


Sponsor

Jin Yang

Enrollment

400 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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.

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Interventions

DEVICETECNIS Toric II (ZCU)

Using TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.

DEVICEAcrySof IQ Toric

Using AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.

DEVICEAT TORBI 709M

Using the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.


Locations(1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT07453992


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