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OpenTrials
Completed

NCT Number: NCT05052242

Evaluation of Ocular Biometry in PACD With Two Swept Source Optical Coherence Tomography Devices

Purpose: To investigate agreement between 2 swept source OCT biometers, IOL M.aster700 and Anterion, in various ocular biometry and intraocular lens (IOL) calculations of primary angle-closure disease (PACD).

Methods: This was a prospective study conducted in a tertiary eye care centre involving biometric measurements obtained with 2 devices in phakic eye with diagnosis of PACD. Mean difference and intraclass correlation coefficient (ICC) with confidence limits were assessed, and calculations of estimated residual refraction of the IOL were analysed using Barrett's formula.

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Key information

Age range

40 year–77 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Somporn Chantra

Bangkok, 10400, Thailand

About this study

Primary angle-closure disease (PACD) is the leading cause of blindness worldwide. PACD is an anatomic disorder, typically of relatively small eye with shallow anterior chamber depth (ACD), thick lens, shorter axial length (AL), small corneal curvature, and relatively anterior lens position. Pupillary block, plateau iris and phacomorphic mechanisms play major roles in the pathophysiology of the disease, and pupillary block is thought to be the most common causal mechanism.

For decades, phacoemulsification and intraocular lens implantation (PEI) has been proposed for initial management of PACD.4 PEI relieves pupillary block, deepening ACD and widening irido-corneal angle.

Biometry is essential in evaluating ocular dimensions and calculating IOL power in PACD, and ocular biometers have been evolving in recent years. Optical coherence tomography (OCT) includes partial coherence interferometry (PCI), and swept source OCT (SS-OCT) is in general use in clinical practice. The agreement of the calculations of these devices has been studied by many investigators; however, research into their agreement in PACD patients has been sparse so far. A newer SS-OCT, Anterion, is now available and its performance needs to be evaluated.

Who can participate

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

Inclusion criteria

  • Inclusion criteria were age > 40 years old
  • phakic eye
  • diagnosis of PACD, including primary angle-closure suspect (PACS), primary angle-closure (PAC) and primary angle-closure glaucoma (PACG) as classified by Foster et al

Exclusion criteria

  • patients who had opaque optical media
  • dense cataract
  • anterior and/or posterior segment diseases such as advanced pterygium, diabetic retinopathy, or maculopathy
  • Participants who had previous history of ocular trauma, ocular surgery

Treatment and study plan

primary angle closure disease

Diagnostic Test

2 swept source OCT biometers, IOL Master700 and Anterion

Primary outcomes

  1. Intraclass correlation coefficient of IOL power calculation

    Time frame: 30 minutes per person

    agreement between 2 swept source OCT biometers, IOL Master700 and Anterion, in intraocular lens (IOL) calculations

  2. Intraclass correlation coefficient of various ocular biometry

    Time frame: 30 minutes per person

    agreement between 2 swept source OCT biometers, IOL Master700 and Anterion, in various ocular biometry( ACD, AL, LT, K1, K2, WTW)

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Evaluation of Ocular Biometry in Primary Angle-closure Disease With Two Swept Source Optical Coherence Tomography Devices

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2021
Registry last updated
Sep 22, 2021

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.

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