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Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs

ConditionCataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJin Yang

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TECNIS Toric II (ZCU)

    Device

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

  • AcrySof IQ Toric

    Device

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

  • AT TORBI 709M

    Device

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

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: TECNIS Toric II (ZCU)Active comparator 1 intervention
Group B: AcrySof IQ ToricActive comparator 1 intervention
Group C: AT TORBI 709MActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Uncorrected and corrected distance visual acuity (UDVA and CDVA)

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.

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

Postoperative residual refractive astigmatism measured in diopters

Residual refractive astigmatism measured by manifest refraction during follow-up visits and reported in diopters (D).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jin Yang

Lead sponsor

Eye & ENT Hospital of Fudan University

Sponsor institution

Source ClinicalTrials.gov
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