- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07710963
Comparison of the Concordance Between Digital Marking and Manual Marking for Toric Intraocular Lens Positioning
Comparison of the Concordance Between Digital Image-Guided Navigation and Manual Peripheral Corneal Marking for Toric Intraocular Lens Positioning
Studienübersicht
Status
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
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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
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
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- MTU-EC-OP-0-162/69
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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