- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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
Typ studiów
Zapisy (Szacowany)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mean signed angular deviation in degrees of the manual slit-lamp horizontal reference mark from the VERION digital reference meridian
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of eyes within ±5° of the VERION digital reference meridian, measured intraoperatively
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- MTU-EC-OP-0-162/69
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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