HUD Surgical Guidance for Toric Alignment

NCT ID: NCT07325188

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-04

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract and IOL Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Surgical guidance for Toric IOL alignment intraoperatively

Interventional

Group Type OTHER

Cassini Guidance

Intervention Type DEVICE

Cassini Guidance with HUD

Interventions

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Cassini Guidance

Cassini Guidance with HUD

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gainesville Eye Associates

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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North Georgia Eye Associates

Gainesville, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dr. Clayton Blehm Blehm, MD

Role: CONTACT

(770) 532-4444

Facility Contacts

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Clayton Blehm Blehm, MD

Role: primary

(770) 532-4444

References

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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.

Reference Type RESULT
PMID: 37400160 (View on PubMed)

Other Identifiers

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2025-0104

Identifier Type: -

Identifier Source: org_study_id

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