Burapha University
Chon Buri, 20131, Thailand
NCT Number: NCT07500272
This study aim to evaluate the agreement of ocular biometric parameters and intraocular lens between two devices (OA-2000 and Pentacam AXL) in patients with cataract.
Participants will be measured ocular biometric parameters once with each device in a random order by the same experienced operator.
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Notify Me18 year and older
All sexes
Observational
Chon Buri, 20131, Thailand
This study was conducted as a prospective cross-sectional study to evaluate Agreement of ocular biometry and intraocular lens power between swept-source optical coherence tomography with Placido-disc topography (OA-2000) and Scheimpflug tomography with partial coherence interferometry (Pentacam AXL) in cataract patients The study performed at the Ophthalmology Outpatient Department, Burapha University Hospital, Chonburi, Thailand. The study protocol adhered to the tenets of the Declaration of Helsinki and received formal approval from the Institutional Review Board, Burapha University. Prior to the commencement of any measurements, all participants acknowledged comprehensive study information and provided written informed consent.
A total of 94 participants, aged 18 years or older, diagnosed with cataracts and scheduled for cataract surgery, were enrolled. Exclusion criteria included history of corneal trauma, prior ocular surgery, the use of contact lenses within two weeks of measurement, and the presence of other concurrent ocular pathologies. For each participant, right eye was preferentially selected for analysis; left eye was only utilized if right eye met any of the predefined exclusion criteria.
Measurement protocol Both devices, OA-2000 and Pentacam AXL Wave were calibrated daily before clinical use to ensure technical accuracy. All measurements were performed by one experienced examiner to eliminate inter-observer variability. Participants were instructed on proper head positioning and fixation, with a complete blink prior to each automated image capture. Measurements were obtained once for each device, with the sequence of instrumentation determined in a random order. The study evaluated several ocular biometric parameters: flat keratometry (K1), steep keratometry (K2), mean keratometry (Km), corneal astigmatism, vector analysis (J0 and J45), ACD, WTW, and AL. For the calculation of IOL power, The Acrysof SN60WF model (Alcon Laboratories, Fort Worth, Texas, USA) was used as the reference, utilizing the keratometric index of 1.3375. IOL power calculations were performed using three distinct formulas: SRK/T, Barrett Universal II, and Hoffer Q.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measurement technology using swept-source optical coherence tomography with Placido-disc topography
Other names: OA-2000
Measurement technology using Scheimpflug tomography with partial coherence interferometry
Other names: Pentacam AXL
Time frame: Immediately after participating in the study
Intraocular lens power calculated using SRK/T, Barrett Universal II, and Hoffer Q formulas in diopters
Time frame: Immediately after participating in the study
flat keratometery(K1) in diopters
Time frame: Immediately after participating in the study
steep keratometry(K2) in diopters
Time frame: Immediately after participating in the study
Mean keratometry(Km) in diopters
Time frame: Immediately after participating in the study
Anterior chamber depth (ACD) in millimeters
Time frame: Immediately after participating in the study
White-to-white distance (WTW) in millimeters
Time frame: Immediately after participating in the study
Axial lenght (AL) in millimeters
Time frame: Immediately after participating in the study
corneal astigmatism in diopters
Time frame: Immediately after participating in the study
J0 is vector analysis of corneal astigmatism; measures astigmatism at 90° and 180°
Time frame: Immediately after participating in the study
J45 is vector analysis of corneal astigmatism; measures astigmatism at 45° and 135°
Burapha University
Other
Agreement of Ocular Biometry and Intraocular Lens Power Between Swept-source Optical Coherence Tomography With Placido-disc Topography and Scheimpflug Tomography With Partial Coherence Interferometry in Cataract Patients
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