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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Intraocular Lens
• Intervention / Treatment: Device: Swept-source optical coherence tomography with Placido-disc topography; Device: Scheimpflug tomography with partial coherence interferometry

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.

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Thailand
  • Chon Buri, Thailand, 20131
    • Burapha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with cataracts and scheduled for cataract surgery at the Ophthalmology Outpatient Department, Burapha University Hospital, Chonburi, Thailand

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cataract patients; Patients with cataract who were scheduled for cataract surgery	Device: Swept-source optical coherence tomography with Placido-disc topography; Measurement technology using swept-source optical coherence tomography with Placido-disc topography; Other Names: OA-2000; Device: Scheimpflug tomography with partial coherence interferometry; Measurement technology using Scheimpflug tomography with partial coherence interferometry; Other Names: Pentacam AXL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of Intraocual lens power between OA-2000 and Pentacam AXL in cataract patients	Intraocular lens power calculated using SRK/T, Barrett Universal II, and Hoffer Q formulas in diopters	Immediately after participating in the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of flat keratometery(K1) between OA-2000 and Pentacam AXL in cataract patients	flat keratometery(K1) in diopters	Immediately after participating in the study
Agreement of steep keratometry(K2) between OA-2000 and Pentacam AXL in cataract patient	steep keratometry(K2) in diopters	Immediately after participating in the study
Agreement of mean keratometry(Km) between OA-2000 and Pentacam AXL in cataract patient	Mean keratometry(Km) in diopters	Immediately after participating in the study
Agreement of anterior chamber depth (ACD) between OA-2000 and Pentacam AXL in cataract patients	Anterior chamber depth (ACD) in millimeters	Immediately after participating in the study
Agreement of white-to-white distance (WTW) between OA-2000 and Pentacam AXL in cataract patients	White-to-white distance (WTW) in millimeters	Immediately after participating in the study
Agreement of axial lenght (AL) between OA-2000 and Pentacam AXL in cataract patients	Axial lenght (AL) in millimeters	Immediately after participating in the study
Agreement of corneal astigmatism between OA-2000 and Pentacam AXL in cataract patients	corneal astigmatism in diopters	Immediately after participating in the study
Agreement of J0 between OA-2000 and Pentacam AXL in cataract patients	J0 is vector analysis of corneal astigmatism; measures astigmatism at 90° and 180°	Immediately after participating in the study
Agreement of J45 between OA-2000 and Pentacam AXL in cataract patients	J45 is vector analysis of corneal astigmatism; measures astigmatism at 45° and 135°	Immediately after participating in the study

Collaborators and Investigators

• Sponsor: Burapha University
• Investigators: Principal Investigator: Rosepon Asawaworarit, M.D., M.Sc., Burapha University

Publications and helpful links

General Publications

• Hua Y, Qiu W, Xiao Q, Wu Q. Precision (repeatability and reproducibility) of ocular parameters obtained by the Tomey OA-2000 biometer compared to the IOLMaster in healthy eyes. PLoS One. 2018 Feb 27;13(2):e0193023. doi: 10.1371/journal.pone.0193023. eCollection 2018.
• Wang W, Miao Y, Savini G, McAlinden C, Chen H, Hu Q, Wang Q, Huang J. Precision of a new ocular biometer in eyes with cataract using swept source optical coherence tomography combined with Placido-disk corneal topography. Sci Rep. 2017 Oct 23;7(1):13736. doi: 10.1038/s41598-017-13800-7.
• Asawaworarit R, Satitpitakul V, Taweekitikul P, Pongpirul K. Agreement of total corneal power between 2 swept-source optical coherence tomography and Scheimpflug tomography in normal and keratoconic patients. PLoS One. 2022 May 24;17(5):e0268856. doi: 10.1371/journal.pone.0268856. eCollection 2022.
• Ruiz-Mesa R, Abengozar-Vela A, Ruiz-Santos M. Comparison of a new Scheimpflug imaging combined with partial coherence interferometry biometer and a low-coherence reflectometry biometer. J Cataract Refract Surg. 2017 Nov;43(11):1406-1412. doi: 10.1016/j.jcrs.2017.08.016.
• Guimaraes de Souza R, Montes de Oca I, Esquenazi I, Al-Mohtaseb Z, Weikert MP. Updates in Biometry. Int Ophthalmol Clin. 2017 Summer;57(3):115-124. doi: 10.1097/IIO.0000000000000175. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cataract; intraocular lens; biometry; keratometry; axial lenght
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IRB1-053/2567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD used in the results publication
• IPD Sharing Time Frame: IPD and supporting information will be available one year after publicaiton and for two years period.
• IPD Sharing Access Criteria: Direct contact to corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No