Cataract and IOL Surgery
Conditions
Keywords
Guidance, Toric IOL
Brief summary
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
DEVICECassini Guidance
Cassini Guidance with HUD
Sponsors
Gainesville Eye Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy (measured in degrees of arc) using the Cassini Guidance system for calculated alignment axis for toric IOL implantation. | Total completion up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time efficiency (measured in seconds) of the Cassini Guidance System in eyes undergoing cataract surgery with toric IOL implantation. | Total completion up to 12 months | 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. |
Countries
United States
Contacts
Primary ContactDr. Clayton Blehm Blehm, MD
Outcome results
None listed