Heads-up display guidance for aligning toric intraocular lenses
Clinical Evaluation of a Novel Intraoperative Guidance System for Accurate Toric IOL Positioning in Cataract Surgery
NA · Gainesville Eye Associates · NCT07325188
This will test whether a digital heads-up guidance system helps surgeons place toric intraocular lenses more accurately during cataract surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gainesville Eye Associates (other) |
| Locations | 1 site (Gainesville, Georgia) |
| Trial ID | NCT07325188 on ClinicalTrials.gov |
What this trial studies
This prospective, non-invasive observational study enrolled 100 eyes at a single site with a single surgeon to examine a digital guidance system (Cassini Technologies) during toric IOL implantation. The system calculated and displayed intraoperative alignment axes, which were compared in degrees to preoperative measurements to quantify alignment accuracy. The study also recorded the time required to initiate the surgical guidance and collected postoperative outcomes including residual refractive astigmatism and Snellen visual acuity at one month. All procedures were uncomplicated cataract operations in eyes meeting strict inclusion and exclusion criteria to minimize confounding ocular pathology.
Who should consider this trial
Good fit: Adults undergoing uncomplicated cataract surgery who will receive a toric intraocular lens, have reliable biometry, and no significant ocular comorbidity or prior refractive surgery are ideal candidates.
Not a fit: Patients with irregular corneal astigmatism, keratoconus, prior refractive surgery, unstable zonules, poor fixation, severe ocular surface disease, or other significant ocular comorbidities are unlikely to benefit from this guidance approach.
Why it matters
Potential benefit: If successful, the guidance system could reduce toric IOL misalignment, lowering residual astigmatism and improving uncorrected vision after cataract surgery.
How similar studies have performed: Other intraoperative digital image-guidance systems have reported improved toric IOL alignment in prior clinical reports, so this approach builds on existing positive evidence though device performance varies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Georgia
- North Georgia Eye Associates — Gainesville, Georgia, United States (RECRUITING)
Study contacts
- Study coordinator: Dr. Clayton Blehm Blehm, MD
- Email: claytonblehm@gmail.com
- Phone: (770) 532-4444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cataract and IOL Surgery, Guidance, Toric IOL