Skip to main content
OpenTrials
Completed

NCT Number: NCT07500272

Agreement of Ocular Biometry and Intraocular Lens Power Between OA-2000 and Pentacam AXL 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Burapha University

Chon Buri, 20131, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swept-source optical coherence tomography with Placido-disc topography

Device

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

Other names: OA-2000

Scheimpflug tomography with partial coherence interferometry

Device

Measurement technology using Scheimpflug tomography with partial coherence interferometry

Other names: Pentacam AXL

Primary outcomes

  1. Agreement of Intraocual lens power between OA-2000 and Pentacam AXL in cataract patients

    Time frame: Immediately after participating in the study

    Intraocular lens power calculated using SRK/T, Barrett Universal II, and Hoffer Q formulas in diopters

Secondary outcomes

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

    Time frame: Immediately after participating in the study

    flat keratometery(K1) in diopters

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

    Time frame: Immediately after participating in the study

    steep keratometry(K2) in diopters

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

    Time frame: Immediately after participating in the study

    Mean keratometry(Km) in diopters

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

    Time frame: Immediately after participating in the study

    Anterior chamber depth (ACD) in millimeters

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

    Time frame: Immediately after participating in the study

    White-to-white distance (WTW) in millimeters

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

    Time frame: Immediately after participating in the study

    Axial lenght (AL) in millimeters

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

    Time frame: Immediately after participating in the study

    corneal astigmatism in diopters

  8. Agreement of J0 between OA-2000 and Pentacam AXL in cataract patients

    Time frame: Immediately after participating in the study

    J0 is vector analysis of corneal astigmatism; measures astigmatism at 90° and 180°

  9. Agreement of J45 between OA-2000 and Pentacam AXL in cataract patients

    Time frame: Immediately after participating in the study

    J45 is vector analysis of corneal astigmatism; measures astigmatism at 45° and 135°

Sponsors and collaborators

Lead sponsor

Burapha University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.