NCT07176897

Refractive Accuracy of Toric Intraocular Lens Implantation Using Digital Marking Compared to Conventional Marking

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Colvard Kandavel Eye Center · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the postoperative refractive accuracy and intraoperative lens rotational placement of a conventional toric intraoperative marking method compared to digital marking.

Detailed description

Preoperative biometry and planning was assessed with the Argos SS-OCT biometer. The ToriCAM application was also used to mark the patient manually at the bedside. A Mendez marker was used to mark the final axis of the IOL, as calculated by Argos. Digital marking was performed using the VERION image guided system. All subjects received both digital and manual marking, and were implanted with Clareon monofocal toric IOLs (CCWOTx) using the digital marker for final IOL alignment. The primary outcome measure was the difference in degrees between the digital marker and the manual marker as measured intraoperatively. Other outcome measures included IOL rotation, residual astigmatism, absolute prediction error (APE), and monocular visual acuity at 2 months postoperatively.

Conditions

• Cataract
• Astigmatism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Normal Toric IOL implantation with digital marking	Digital marking was compared to bedside marking, but there was no change in clinical practice. The difference in the marks was measured.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-03-12
• Completion: 2025-03-12
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study