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

13. Juli 2026 aktualisiert von: Pirapat Chareonboonsit, Thammasat University

Comparison of the Concordance Between Digital Image-Guided Navigation and Manual Peripheral Corneal Marking for Toric Intraocular Lens Positioning

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

100

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Cataract Patients at Thammasat University

Beschreibung

Inclusion Criteria:

  • candidates for uncomplicated cataract surgery

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean signed angular deviation in degrees of the manual slit-lamp horizontal reference mark from the VERION digital reference meridian
Zeitfenster: 6 months
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of eyes within ±5° of the VERION digital reference meridian, measured intraoperatively
Zeitfenster: 6 months
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.
6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Juli 2026

Primärer Abschluss (Geschätzt)

30. September 2026

Studienabschluss (Geschätzt)

30. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

8. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juli 2026

Zuerst gepostet (Tatsächlich)

17. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • MTU-EC-OP-0-162/69

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Verion Digital Marking

3
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