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

Completed

• Conditions: Primary Angle Closure Glaucoma
• Interventions: Diagnostic Test: primary angle closure disease

• Registration Number: NCT05052242
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-05-01
• Primary Completion: 2021-08-31
• Status Verified: 2021-09
• Study Completion: 2021-09-03
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Study First Posted: 2021-09-22
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
one group compared two measurement methods	primary angle closure disease	one group compared two measurement methods

Primary Outcome Measures

Name	Time	Method
Intraclass correlation coefficient of various ocular biometry	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)
Intraclass correlation coefficient of IOL power calculation	30 minutes per person	agreement between 2 swept source OCT biometers, IOL Master700 and Anterion, in intraocular lens (IOL) calculations

Trial Locations

Locations (1)

Somporn Chantra; 🇹🇭 Bangkok, Thailand