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NCT Number: NCT07325188

HUD Surgical Guidance for Toric Alignment

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.

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Key information

Conditions

Cataract and IOL Surgery Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Georgia Eye Associates

Gainesville, Georgia, 30501, United States

Location status: Recruiting

Location contact

Clayton Blehm Blehm, MD

CONTACT

[email protected]

(770) 532-4444

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Cassini Guidance

Device

Cassini Guidance with HUD

Primary outcomes

  1. Accuracy (measured in degrees of arc) using the Cassini Guidance system for calculated alignment axis for toric IOL implantation.

    Time frame: Total completion up to 12 months

    Primary Endpoint:

    • Accuracy of the calculated alignment axis (degrees of arc = angular degrees)
    • Definition: The angular difference between the alignment axis for toric IOLs as determined with the CGS and the intended alignment axis as determined with the Cassini Ambient.
    • Thresholds of interest: ≤3°, ≤5°, ≤10°, >10°.
    • Justification: Misalignment greater than 10° results in a clinically significant loss of toric correction (approximately 33%) (Quesada et al., 2022; Hu, 2023), making this a meaningful accuracy benchmark.

Secondary outcomes

  1. Time efficiency (measured in seconds) of the Cassini Guidance System in eyes undergoing cataract surgery with toric IOL implantation.

    Time frame: Total completion up to 12 months

    Secondary Endpoint:

    • The time (measured in seconds) required to initiate (0 seconds) and finish (x seconds) surgical guidance using the Cassini Guidance System in 100 eyes undergoing toric IOL implantation.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Clayton Blehm Blehm, MD

CONTACT

[email protected]

(770) 532-4444

Sponsors and collaborators

Lead sponsor

Gainesville Eye Associates

Other

Registry information

Official study title

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

Acronym: CG-Toric

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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