Comparison of the Concordance Between Digital Marking and Manual Marking for Toric Intraocular Lens Positioning

NCT07710963 | Not Yet Recruiting

• 1 other identifier: MTU-EC-OP-0-162/69
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This cross-sectional comparative study evaluated patients from a single cataract center. In each eye, manual horizontal meridian axis line was marked on the cornea using the manual peripheral corneal marking technique (Horizontal Slit Beam Marking ), while the Verion digital image-guided navigation system provided a reference axis fixed at the horizontal meridian (0°/180°). The primary outcome measure was the difference in degrees between the digital marker and the manual marker horizontal meridian as measured intraoperatively. Agreement was assessed using Bland-Altman analysis, reporting the mean bias (systematic error) and 95% limits of agreement (LoA, mean ± 1.96 SD). A misalignment of ±10° was defined as the threshold of clinical significance.

Conditions

Cataract Surgeries

Keywords

manual marking; digital marking; toric intraocular lens

Outcome Measures

Primary Outcomes (1)

• Mean signed angular deviation in degrees of the manual slit-lamp horizontal reference mark from the VERION digital reference meridian

  For each eye, the signed angular difference (degrees) between the horizontal reference meridian (0-180°) marked by the manual slit-lamp peripheral corneal marking technique and the corresponding meridian identified by the VERION Image-Guided System (reference standard) is measured intraoperatively. Clockwise deviation is coded positive and counterclockwise negative. Agreement is summarized across eyes as the mean signed angular deviation with 95% Bland-Altman limits of agreement. Reported in a single unit (degrees).

  6 months

Secondary Outcomes (1)

• Proportion of eyes within ±5° of the VERION digital reference meridian, measured intraoperatively

  6 months

Interventions

Verion Digital Marking OTHER

Verion Digital Marking Vs Manual Marking

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cataract Patients at Thammasat University

You may qualify if:

• candidates for uncomplicated cataract surgery

You may not qualify if:

• irregular corneal astigmatism, lens subluxation, uveitis, glaucoma, trauma, history of retinal disease or optic neuropathy, previous intraocular or corneal surgery and corneal disease that could not be evaluated by the ARGOS or VERION systems

Sponsors & Collaborators

• Thammasat University: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 17, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07