NCT07500272

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
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Burapha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract
• Intraocular Lens

Interventions

Type	Name	Description
DEVICE	Swept-source optical coherence tomography with Placido-disc topography	Measurement technology using swept-source optical coherence tomography with Placido-disc topography
DEVICE	Scheimpflug tomography with partial coherence interferometry	Measurement technology using Scheimpflug tomography with partial coherence interferometry

Timeline

• Start date: 2024-09-02
• Primary completion: 2024-11-29
• Completion: 2024-11-29
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Thailand