HUD Surgical Guidance for Toric Alignment
ConditionCataract and IOL Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGainesville Eye Associates
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing uncomplicated cataract surgery with toric IOL implantation,
Eyes implanted with a toric IOL.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cassini Guidance
DeviceCassini Guidance with HUD
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Surgical guidance for Toric IOL alignment intraoperativelyOther 1 intervention
Trial outcomes
Primary outcomes
1
Accuracy (measured in degrees of arc) using the Cassini Guidance system for calculated alignment axis for toric IOL implantation.
Primary Endpoint: 1\. 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.
Time frame
Total completion up to 12 monthsSecondary outcomes
1
Time efficiency (measured in seconds) of the Cassini Guidance System in eyes undergoing cataract surgery with toric IOL implantation.
Secondary Endpoint: 1\. 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.
Time frame
Total completion up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov