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

September 12, 2025 updated by: Ganesha Kandavel, Colvard Kandavel Eye Center
To evaluate the postoperative refractive accuracy and intraoperative lens rotational placement of a conventional toric intraoperative marking method compared to digital marking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Colvard-Kandavel Eye Center
      • Encino, California, United States, 91316
        • Freedom Vision Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Los Angeles Ophthalmology General practice all ages > 12 years of age.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Toric Lens Patients
These patients had selected to have laser cataract surgery with an astigmatism-correcting lens
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in degrees between the digital marker and the manual marker as measured intraoperatively
Time Frame: From enrollment to the end of post-operative period at 2 months
From enrollment to the end of post-operative period at 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
IOL rotation
Time Frame: From enrollment to the end of post-operative period at 2 months
From enrollment to the end of post-operative period at 2 months
Residual Astigmatism
Time Frame: From enrollment to the end of post-operative period at 2 months
From enrollment to the end of post-operative period at 2 months
Absolute Prediction Error (APE)
Time Frame: From enrollment to the end of post-operative period at 2 months
From enrollment to the end of post-operative period at 2 months
Monocular Visual Acuity
Time Frame: From enrollment to the end of post-operative period at 2 months
From enrollment to the end of post-operative period at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colvard Kandavel Eye Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

March 12, 2025

Study Completion (Actual)

March 12, 2025

Study Registration Dates

First Submitted

August 27, 2025

First Submitted That Met QC Criteria

September 12, 2025

First Posted (Estimated)

September 16, 2025

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9216252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This data is not relevant to research outside of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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