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

NCT05052242 | Completed

• 1 other identifier: Rajavithi hospital
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Angle Closure Glaucoma

Keywords

Ocular biometry; swept source OCT; agreement

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

one group compared two measurement methods

one group compared two measurement methods

Diagnostic Test: primary angle closure disease

Interventions

primary angle closure disease DIAGNOSTIC_TEST

2 swept source OCT biometers, IOL Master700 and Anterion

one group compared two measurement methods

Eligibility Criteria

• Age: 40 Years - 77 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Somporn Chantra

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Somporn Chantra, MD

  Department of Medical Services Ministry of Public Health of Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 22, 2021
• Study Start: May 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: September 3, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)