Recruiting

Toric IOL

Sponsor:

Gainesville Eye Associates

Code:

NCT07325188

Conditions

Cataract and IOL Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cassini Guidance

Study Details

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.

Conditions

Cataract and IOL Surgery

Study ID

NCT07325188

Start date

Nov 4, 2025

Status verified date

Jan, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Surgical guidance for Toric IOL alignment intraoperatively

Interventional

Interventions

Cassini Guidance

Cassini Guidance with HUD

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Dr. Clayton Blehm Blehm, MD

(770) 532-4444claytonblehm@gmail.com

Locations

North Georgia Eye Associates

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

Clayton Blehm Blehm, MD

(770) 532-4444claytonblehm@gmail.com

More Information

Sponsor

Gainesville Eye Associates

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Guidance
  • Toric IOL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Gainesville Eye Associates on 2026-01-08.