Clinical trial NCT05052242: Evaluation of Ocular Biometry in PACD With Two Swept Source Optical Coherence Tomography Devices
Official title: Evaluation of Ocular Biometry in Primary Angle-closure Disease With Two Swept Source Optical Coherence Tomography Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Angle Closure Glaucoma
Keywords: Ocular biometry
swept source OCT
agreement
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2021-09-22
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants from the glaucoma clinic at Rajavithi Hospital, Bangkok, Thailand. between May and December 2020

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraclass correlation coefficient of IOL power calculation
timeFrame: 30 minutes per person
measure: Intraclass correlation coefficient of various ocular biometry
timeFrame: 30 minutes per person
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Somporn Chantra
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Somporn Chantra, MD
role: PRINCIPAL_INVESTIGATOR
References: