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Agreement of Ocular Biometry and Intraocular Lens Power Between OA-2000 and Pentacam AXL in Cataract Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07500272
Enrollment
94
Registered
2026-03-30
Start date
2024-09-02
Completion date
2024-11-29
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Intraocular Lens

Keywords

biometry, keratometry, axial lenght, intraocular lens, cataract

Brief summary

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.

Detailed description

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.

Interventions

DEVICESwept-source optical coherence tomography with Placido-disc topography

Measurement technology using swept-source optical coherence tomography with Placido-disc topography

DEVICEScheimpflug tomography with partial coherence interferometry

Measurement technology using Scheimpflug tomography with partial coherence interferometry

Sponsors

Burapha University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants aged 18 years or older, diagnosed with cataracts and scheduled for cataract surgery

Exclusion criteria

* History of corneal trauma * Prior ocular surgery * The use of contact lenses within two weeks of measurement * The presence of other concurrent ocular pathologies

Design outcomes

Primary

MeasureTime frameDescription
Agreement of Intraocual lens power between OA-2000 and Pentacam AXL in cataract patientsImmediately after participating in the studyIntraocular lens power calculated using SRK/T, Barrett Universal II, and Hoffer Q formulas in diopters

Secondary

MeasureTime frameDescription
Agreement of flat keratometery(K1) between OA-2000 and Pentacam AXL in cataract patientsImmediately after participating in the studyflat keratometery(K1) in diopters
Agreement of steep keratometry(K2) between OA-2000 and Pentacam AXL in cataract patientImmediately after participating in the studysteep keratometry(K2) in diopters
Agreement of mean keratometry(Km) between OA-2000 and Pentacam AXL in cataract patientImmediately after participating in the studyMean keratometry(Km) in diopters
Agreement of anterior chamber depth (ACD) between OA-2000 and Pentacam AXL in cataract patientsImmediately after participating in the studyAnterior chamber depth (ACD) in millimeters
Agreement of white-to-white distance (WTW) between OA-2000 and Pentacam AXL in cataract patientsImmediately after participating in the studyWhite-to-white distance (WTW) in millimeters
Agreement of axial lenght (AL) between OA-2000 and Pentacam AXL in cataract patientsImmediately after participating in the studyAxial lenght (AL) in millimeters
Agreement of corneal astigmatism between OA-2000 and Pentacam AXL in cataract patientsImmediately after participating in the studycorneal astigmatism in diopters
Agreement of J0 between OA-2000 and Pentacam AXL in cataract patientsImmediately after participating in the studyJ0 is vector analysis of corneal astigmatism; measures astigmatism at 90° and 180°
Agreement of J45 between OA-2000 and Pentacam AXL in cataract patientsImmediately after participating in the studyJ45 is vector analysis of corneal astigmatism; measures astigmatism at 45° and 135°

Countries

Thailand

Contacts

PRINCIPAL_INVESTIGATORRosepon Asawaworarit, M.D., M.Sc.

Burapha University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026