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

Sponsor
Rajavithi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05052242
Collaborator
(none)
45
1
16.1
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of Ocular Biometry in Primary Angle-closure Disease With Two Swept Source Optical Coherence Tomography Devices
Actual Study Start Date :
May 1, 2020
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Sep 3, 2021

Arms and Interventions

Arm Intervention/Treatment
one group compared two measurement methods

one group compared two measurement methods

Diagnostic Test: primary angle closure disease
2 swept source OCT biometers, IOL Master700 and Anterion

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 77 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Somporn Chantra Bangkok Thailand 10400

Sponsors and Collaborators

  • Rajavithi Hospital

Investigators

  • Principal Investigator: Somporn Chantra, MD, Rajavithi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT05052242
Other Study ID Numbers:
  • Rajavithi hospital
First Posted:
Sep 22, 2021
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rajavithi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2021