HUD Surgical Guidance for Toric Alignment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cassini Guidance.
- Who it may be relevant to
- Registry conditions: Cataract and IOL Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Evaluation of a Novel Intraoperative Guidance System for Accurate Toric IOL Positioning in Cataract Surgery
Overview
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.
Interventions
- Device Cassini Guidance
Cassini Guidance with HUD
Primary outcome measures
- 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]
Secondary outcome measures (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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- North Georgia Eye Associates — Gainesville
Publications
- 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. PMID 37400160
Identifiers
NCT: NCT07325188 · 2025-0104