HUD Surgical Guidance for Toric Alignment

Part of paid clinical trials in Gainesville, Georgia.

Sponsor
Gainesville Eye Associates
Study ID
NCT07325188
Status
Recruiting
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Conditions

  • Cataract and IOL Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cassini Guidance — DEVICE
    Cassini Guidance with HUD

Study Details

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.

Key Dates

Start date
Nov 4, 2025
Status verified
Jan 2026
Primary completion
Oct 1, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Surgical guidance for Toric IOL alignment intraoperatively
    Interventional

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
North Georgia Eye AssociatesGainesvilleGeorgia30501
Clayton Blehm Blehm, MD
[email protected]
(770) 532-4444

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By research site
North Georgia Eye Associates· Gainesville, GA

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