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CataractNCT07500272

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

An observational study of Cataract and Intraocular Lens, run by Burapha University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract, Intraocular Lens
What is being tested?
Swept-source optical coherence tomography with Placido-disc topography and Scheimpflug tomography with partial coherence interferometry
Type of treatment
Medical device
How many people
94 participants
Where
1 siteThailand
Study dates
2 Sep 2024to 29 Nov 2024
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Burapha University

    Chon Buri, 20131

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
Swept-source optical coherence tomography with Placido-disc topography, Scheimpflug tomography with partial coherence interferometry
Keywords
biometry, keratometry, axial lenght, intraocular lens, cataract
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Swept-source optical coherence tomography with Placido-disc topographyDevice

    Also called OA-2000

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

  • Scheimpflug tomography with partial coherence interferometryDevice

    Also called Pentacam AXL

    Measurement technology using Scheimpflug tomography with partial coherence interferometry

Study groups in NCT07500272
Study groupRoleWhat they receive
Cataract patientsPatients with cataract who were scheduled for cataract surgery
Receives: Device: Swept-source optical coherence tomography with Placido-disc topography; Device: Scheimpflug tomography with partial coherence interferometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Immediately after participating in the study

Secondary outcomes (9)

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

    flat keratometery(K1) in diopters

    Measured: Immediately after participating in the study

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

    steep keratometry(K2) in diopters

    Measured: Immediately after participating in the study

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

    Mean keratometry(Km) in diopters

    Measured: Immediately after participating in the study

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

    Anterior chamber depth (ACD) in millimeters

    Measured: Immediately after participating in the study

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

    White-to-white distance (WTW) in millimeters

    Measured: Immediately after participating in the study

  6. Agreement of axial lenght (AL) between OA-2000 and Pentacam AXL in cataract patients

    Axial lenght (AL) in millimeters

    Measured: Immediately after participating in the study

  7. Agreement of corneal astigmatism between OA-2000 and Pentacam AXL in cataract patients

    corneal astigmatism in diopters

    Measured: Immediately after participating in the study

  8. 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°

    Measured: Immediately after participating in the study

  9. 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°

    Measured: Immediately after participating in the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start2 Sep 2024
  3. Primary completion29 Nov 2024
  4. Study completion29 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
94 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07500272
Sponsor's protocol ID
IRB1-053/2567
Status last verified
Mar 2026
First submitted
18 Mar 2026
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD used in the results publication

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.

    PubMed 29486009

  • 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.

    PubMed 29061989

  • 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.

    PubMed 35609043

  • 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.

    PubMed 29223229

  • 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.

    PubMed 28590285

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Intraocular Lens, run by Burapha University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement of Intraocual lens power between OA-2000 and Pentacam AXL in cataract patients (time frame: Immediately after participating in the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07500272, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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