ClinicalTrials.gg
CompletedNCT05052242Updated Sep 22, 2021

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

An observational study in Primary Angle Closure Glaucoma, sponsored by Rajavithi Hospital. Completed at 1 site in Thailand. Open to participants aged 40 Years to 77 Years. Per ClinicalTrials.gov, last updated 2021-09-22.

Sponsored by Rajavithi Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
45
Ages
40 Years to 77 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Angle Closure Glaucoma

Keywords

  • Ocular biometry
  • swept source OCT
  • agreement
03

In context

Glaucoma, Angle-Closure

91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.

This study's enrollment of 45 is below the median of 225 across 32 observational studies indexed under Glaucoma, Angle-Closure.

Browse Glaucoma, Angle-Closure studies →

Lead sponsor

Rajavithi Hospital is the lead sponsor of 46 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 77 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • one group compared two measurement methods

    one group compared two measurement methods

    Diagnostic Test: primary angle closure disease

Interventions

  • Diagnostic testprimary angle closure disease

    2 swept source OCT biometers, IOL Master700 and Anterion

06

What researchers measure

Primary outcomes

  1. Intraclass correlation coefficient of IOL power calculation

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

    Time frame: 30 minutes per person

  2. 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)

    Time frame: 30 minutes per person

07

Study locations

1 site
  • Somporn Chantra
    Bangkok, 10400, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2020 to primary completion in Aug 2021, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2021
First posted
Sep 22, 2021
StartActual
May 1, 2020
Primary completionActual
Aug 31, 2021
CompletionActual
Sep 3, 2021
Last update
Sep 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05052242
Lead sponsor
Rajavithi Hospital
Responsible party
Sponsor
First posted
Sep 22, 2021
Start date
May 1, 2020
Primary completion
Aug 31, 2021
Completion
Sep 3, 2021
Last update
Sep 22, 2021

Study contacts

Somporn Chantra, MD
principal investigator · Rajavithi Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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