HUD Surgical Guidance for Toric Alignment

NCT07325188 | Recruiting FDA Device

• 1 other identifier: 2025-0104
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Guidance; Toric IOL

Outcome Measures

Primary Outcomes (1)

• Accuracy (measured in degrees of arc) using the Cassini Guidance system for calculated alignment axis for toric IOL implantation.

  Primary Endpoint: 1\. Accuracy of the calculated alignment axis (degrees of arc = angular degrees) * Definition: The angular difference between the alignment axis for toric IOLs as determined with the CGS and the intended alignment axis as determined with the Cassini Ambient. * Thresholds of interest: ≤3°, ≤5°, ≤10°, \>10°. * Justification: Misalignment greater than 10° results in a clinically significant loss of toric correction (approximately 33%) (Quesada et al., 2022; Hu, 2023), making this a meaningful accuracy benchmark.

  Total completion up to 12 months

Secondary Outcomes (1)

• Time efficiency (measured in seconds) of the Cassini Guidance System in eyes undergoing cataract surgery with toric IOL implantation.

  Total completion up to 12 months

Study Arms (1)

Surgical guidance for Toric IOL alignment intraoperatively

OTHER

Interventional

Device: Cassini Guidance

Interventions

Cassini Guidance DEVICE

Cassini Guidance with HUD

Surgical guidance for Toric IOL alignment intraoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing uncomplicated cataract surgery with toric IOL implantation,
• Eyes implanted with a toric IOL.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gainesville Eye Associates: lead

Study Sites (1)

North Georgia Eye Associates

Gainesville, Georgia, 30501, United States

RECRUITING

Related Publications (1)

• Yao L, Jia S, Yang X, Li M, Yu X, Zhao P, Bai H. Image-Guided Marking versus Manual Marking in Phacoemulsification with Toric Intraocular Lens (IOL) Implantation: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Semin Ophthalmol. 2024 Jan;39(1):60-65. doi: 10.1080/08820538.2023.2231575. Epub 2023 Jul 3.

  PMID: 37400160 RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Dr. Clayton Blehm Blehm, MD

CONTACT

(770) 532-4444; claytonblehm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 8, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)