Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-04
2026-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Surgical guidance for Toric IOL alignment intraoperatively
Interventional
Cassini Guidance
Cassini Guidance with HUD
Interventions
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Cassini Guidance
Cassini Guidance with HUD
Eligibility Criteria
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Inclusion Criteria
* Eyes implanted with a toric IOL.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gainesville Eye Associates
OTHER
Responsible Party
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Locations
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North Georgia Eye Associates
Gainesville, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Yao L, Jia S, Yang X, Li M, Yu X, Zhao P, Bai H. Image-Guided Marking versus Manual Marking in Phacoemulsification with Toric Intraocular Lens (IOL) Implantation: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Semin Ophthalmol. 2024 Jan;39(1):60-65. doi: 10.1080/08820538.2023.2231575. Epub 2023 Jul 3.
Other Identifiers
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2025-0104
Identifier Type: -
Identifier Source: org_study_id
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