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

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 design

Treatments tested in this trial

  • Verion Digital Marking

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Thammasat University

Lead sponsor

Thammasat University Hospital

Sponsor institution