Clinical Evaluation of a Novel Intraoperative Guidance System for Accurate Toric IOL Positioning in Cataract Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients undergoing uncomplicated cataract surgery with toric IOL implantation,

• Eyes implanted with a toric IOL.

Locations
United States
Georgia
North Georgia Eye Associates
RECRUITING
Gainesville
Contact Information
Primary
Dr. Clayton Blehm Blehm, MD
claytonblehm@gmail.com
(770) 532-4444
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 100
Treatments
Other: Surgical guidance for Toric IOL alignment intraoperatively
Interventional
Related Therapeutic Areas
Sponsors
Leads: Gainesville Eye Associates

This content was sourced from clinicaltrials.gov