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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorThammasat University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

candidates for uncomplicated cataract surgery

Disqualifiers

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

Trial population

Cataract Patients at Thammasat University

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Verion Digital Marking

    Other intervention

    Verion Digital Marking Vs Manual Marking

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Thammasat University

Lead sponsor

Thammasat University Hospital

Sponsor institution

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