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Not yet recruitingNCT07710963Updated Jul 17, 2026

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

An observational study in Cataract Surgeries, sponsored by Thammasat University. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Thammasat University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
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Study 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.

Read the detailed description

Patients with visually significant cataract and regular corneal astigmatism who were scheduled for phacoemulsification were screened for eligibility. Inclusion criteria were adults (18 -90 years of age) that were candidates for uncomplicated cataract surgery. The exclusion criteria were 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.

Preoperative assessment included best-corrected visual acuity (BCVA), which were determined by Snellen's chart and converted to logMAR. Spherical equivalent (SE) and astigmatic refraction (AR) were examined by Full Auto Ref-Keratometer (RK-F2, Canon). Evaluation for corneal astigmatism and axial length with ARGOS® Biometer. Slit lamp examination (BP 900®, Hagg-Streit) intraocular pressure measurement (Canon TX-20P), and dilated retinal examination was performed on all of the patients.

For manual technique a slit-lamp was used. Patients were seated with their head fixed with the horizontal supporting band and their chin placed in the center of the chinrest. A thin horizontal slit beam is projected onto the cornea and moved vertically (up and down) until the area of maximum light concentration (brightest reflection) on the corneal surface is identified. For each eye, after identifying the point of maximum light reflex, under topical anesthesia with 0.5% proparacaine hydrochloride eye drops, the corneal limbus was marked at the 0° and 180° meridian (3 and 9 o'clock) positions using a blunt tip of the Sinskey hook coated with sterile gentian violet ink, using light pressure as a single touch of approximately one second, in order to standardize ink deposition and minimize ink spread. The marking was maintained horizontally without any movement during the marking. The thickness of marks was routinely less than 0.25 mm

For the digital technique, preoperative biometry data obtained from the ARGOS Biometer were entered into the Alcon Vision Planner v1.6, which was paired with the VERION Image-Guided System (Alcon Laboratories, Inc., Fort Worth, Texas, USA) to project the digital overlays directly into the operating microscope. This module captures a high-resolution preoperative reference image of the eye which can be used to document the center of the undilated pupil, corneal reflex position or eccentricity of the visual axis, scleral vessels and iris structures. All marking was performed by the same experienced surgeon (W. Tattiyakul) who was experienced with using all techniques, performed all procedures and measurements. No complications had occurred.

With both the manual and digital marks visible intraoperatively, the angular deviation along the horizontal meridian (in degrees) between the manual mark and the digital reference was recorded from the operating-microscope display for each eye by two trained observers independently, each blinded to the other's readings, using the same standardized display. The mean of the two observers' readings was used for all subsequent analyses, and inter-observer agreement was assessed using the intraclass correlation coefficient (ICC) and Bland-Altman analysis

02

Conditions studied

  • Cataract Surgeries

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Keywords

  • manual marking
  • digital marking
  • toric intraocular lens
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 100 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cataract Patients at Thammasat University

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • candidates for uncomplicated cataract surgery

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherVerion Digital Marking

    Verion Digital Marking Vs Manual Marking

06

What researchers measure

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).

    Time frame: 6 months

Secondary outcomes

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

    For each eye, the absolute angular difference (degrees) between the horizontal reference meridian marked by the manual slit-lamp peripheral corneal marking technique and the meridian identified by the VERION Image-Guided System (reference standard) is measured intraoperatively. The outcome is the proportion of eyes with an absolute deviation of 5° or less, reported as a percentage (%) of eyes assessed. ±5° is the pre-specified threshold of clinically acceptable agreement for the marking step.

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07710963
Lead sponsor
Thammasat University
Responsible party
Pirapat Chareonboonsit (Doctor, Thammasat University Hospital) — Principal investigator
First posted
Jul 17, 2026
Start date
Jul 10, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Jul 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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