Heads-up display guidance for aligning toric intraocular lenses
Official title: Clinical Evaluation of a Novel Intraoperative Guidance System for Accurate Toric IOL Positioning in Cataract Surgery
Run by Gainesville Eye Associates · NCT07325188 · Data updated 2026-11-12
This will test whether a digital heads-up guidance system helps surgeons place toric intraocular lenses more accurately during cataract surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Gainesville Eye Associates Academic / other |
| Locations | 1 site (Gainesville, Georgia) |
| Status | Recruiting |
| Started | November 4, 2025 |
| Main results expected | October 1, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT07325188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.