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

NCT07500272 | Completed

• 1 other identifier: IRB1-053/2567
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Intraocular Lens

Keywords

biometry; keratometry; axial lenght; intraocular lens; cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Agreement of flat keratometery(K1) between OA-2000 and Pentacam AXL in cataract patients

  Immediately after participating in the study

• Agreement of steep keratometry(K2) between OA-2000 and Pentacam AXL in cataract patient

  Immediately after participating in the study

• Agreement of mean keratometry(Km) between OA-2000 and Pentacam AXL in cataract patient

  Immediately after participating in the study

• Agreement of anterior chamber depth (ACD) between OA-2000 and Pentacam AXL in cataract patients

  Immediately after participating in the study

• Agreement of white-to-white distance (WTW) between OA-2000 and Pentacam AXL in cataract patients

  Immediately after participating in the study

Study Arms (1)

Cataract patients

Patients with cataract who were scheduled for cataract surgery

Device: Swept-source optical coherence tomography with Placido-disc topography; Device: Scheimpflug tomography with partial coherence interferometry

Interventions

Swept-source optical coherence tomography with Placido-disc topography DEVICE

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

Also known as: OA-2000

Cataract patients

Scheimpflug tomography with partial coherence interferometry DEVICE

Measurement technology using Scheimpflug tomography with partial coherence interferometry

Also known as: Pentacam AXL

Cataract patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Burapha University: lead

Study Sites (1)

Burapha University

Chon Buri, 20131, Thailand

Location

Related Publications (5)

• 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.

  PMID: 29486009 BACKGROUND

• 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.

  PMID: 29061989 BACKGROUND

• 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.

  PMID: 35609043 BACKGROUND

• 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.

  PMID: 29223229 BACKGROUND

• 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.

  PMID: 28590285 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Rosepon Asawaworarit, M.D., M.Sc.

  Burapha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 30, 2026
• Study Start: September 2, 2024
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available one year after publicaiton and for two years period.
• Access Criteria: Direct contact to corresponding author

Locations

TH (1)