RecruitingNot ApplicableNCT07325188

HUD Surgical Guidance for Toric Alignment

Clinical Evaluation of a Novel Intraoperative Guidance System for Accurate Toric IOL Positioning in Cataract Surgery


Sponsor

Gainesville Eye Associates

Enrollment

100 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to assess the accuracy of toric intraocular lens (IOL) alignment axes as calculated and displayed by a novel digital guidance system. In addition, it evaluates the time required to initiate surgical guidance and postoperative refractive astigmatism following toric IOL implantation. This single-surgeon, single-site, prospective, non-invasive observational study evaluated the accuracy of toric IOL alignment axes calculated and displayed by the digital guidance system (Cassini Technologies, B.V.) in 100 eyes. The intraoperatively calculated alignment axes were compared to preoperative measurements to assess their accuracy (in degrees). Postoperative outcomes, including residual refractive astigmatism (diopters) and visual acuity (Snellen), were recorded at 1 month postoperatively.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Patients undergoing uncomplicated cataract surgery with toric IOL implantation,
  • Eyes implanted with a toric IOL.

Exclusion Criteria7

  • Ocular comorbidity likely to impair postoperative visual acuities, or
  • History of ocular trauma or zonular instability, or
  • Previous refractive surgery, or
  • Irregular corneal astigmatism or keratoconus, or
  • Patients with physical or intellectual disabilities that may prevent reliable fixation or comprehension (e.g. Down's Syndrome, Parkinson's Disease), or
  • Patients with unreliable biometry measurements, or
  • Severe dry eye disease or ocular surface disease.

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Interventions

DEVICECassini Guidance

Cassini Guidance with HUD


Locations(1)

North Georgia Eye Associates

Gainesville, Georgia, United States

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NCT07325188


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