Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs

NCT07453992 | Recruiting

• 2 other identifiers: Totic-2026-00182171039
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract

Keywords

toric intraocular lens; rotational stability; cataract; astigmatism

Outcome Measures

Primary Outcomes (1)

• Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees

  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 Outcomes (2)

• Uncorrected and corrected distance visual acuity (UDVA and CDVA)

  postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months

• Postoperative residual refractive astigmatism measured in diopters

  Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.

Study Arms (3)

TECNIS Toric II (ZCU)

ACTIVE COMPARATOR

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)

AcrySof IQ Toric

ACTIVE COMPARATOR

Participants randomized to this arm receive implantation of the AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.

Device: AcrySof IQ Toric

AT TORBI 709M

ACTIVE COMPARATOR

Participants randomized to this arm receive implantation of the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.

Device: AT TORBI 709M

Interventions

TECNIS Toric II (ZCU) DEVICE

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

TECNIS Toric II (ZCU)

AcrySof IQ Toric DEVICE

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

AcrySof IQ Toric

AT TORBI 709M DEVICE

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

AT TORBI 709M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jin Yang: lead

Study Sites (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Jin Yang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuanqiao Lin

CONTACT

+8615088920668; 1532483480@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessors were masked to IOL type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: March 6, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)