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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07176897
Enrollment
41
Registered
2025-09-16
Start date
2024-06-01
Completion date
2025-03-12
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Cataract

Keywords

Cataract, Toric, Astigmatism, Digital Marking, Laser cataract surgery, cataract surgery

Brief 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.

Interventions

DIAGNOSTIC_TESTNormal 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.

Sponsors

Colvard Kandavel Eye Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Adults (50-90 years of age) that were candidates for uncomplicated cataract surgery and planned to be implanted with toric IOLs (CCWOTx, Alcon Vision, LLC)

Exclusion criteria

* History of amblyopia * History of macular disease * History of glaucoma * History of corneal disease * History of prior corneal surgery * History of diabetes * History of ocular comorbidity that might hamper post operative visual acuity * History of previous ocular or refractive surgery with expected post-op VA worse than 0.10 logMAR * History of irregular corneal astigmatism and keratoconus, or severe/uncontrolled ocular surface disease or dry eye disease.

Design outcomes

Primary

MeasureTime frame
difference in degrees between the digital marker and the manual marker as measured intraoperativelyFrom enrollment to the end of post-operative period at 2 months

Secondary

MeasureTime frame
Absolute Prediction Error (APE)From enrollment to the end of post-operative period at 2 months
Monocular Visual AcuityFrom enrollment to the end of post-operative period at 2 months
IOL rotationFrom enrollment to the end of post-operative period at 2 months
Residual AstigmatismFrom enrollment to the end of post-operative period at 2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026