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

Evaluation of Ocular Biometry in Primary Angle-closure Disease 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.

Study Overview

• Status: Completed
• Conditions: Primary Angle Closure Glaucoma
• Intervention / Treatment: Diagnostic test: primary angle closure disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Somporn Chantra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

participants from the glaucoma clinic at Rajavithi Hospital, Bangkok, Thailand. between May and December 2020

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
one group compared two measurement methods	Diagnostic test: primary angle closure disease; 2 swept source OCT biometers, IOL Master700 and Anterion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraclass correlation coefficient of IOL power calculation	agreement between 2 swept source OCT biometers, IOL Master700 and Anterion, in intraocular lens (IOL) calculations	30 minutes per person
Intraclass correlation coefficient of various ocular biometry	agreement between 2 swept source OCT biometers, IOL Master700 and Anterion, in various ocular biometry( ACD, AL, LT, K1, K2, WTW)	30 minutes per person

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Principal Investigator: Somporn Chantra, MD, Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: agreement; Ocular biometry; swept source OCT
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Angle-Closure
• Other Study ID Numbers: Rajavithi Hospital (Other Grant/Funding Number: Rajavithi Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No