Repeatability in Measurements of Two ssOCT and One OLCR Biometer
Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer
1 other identifier
interventional
50
1 country
1
Brief Summary
Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one. Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2019
CompletedFirst Submitted
Initial submission to the registry
January 31, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedOctober 1, 2020
September 1, 2020
4 months
January 31, 2020
September 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of repeatability between two ss-OCT and one OLCR biometry device
Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between two ss-OCT and the OLCR biometry device will be calculated for all the parameters (axial length, keratometry, anterior chamber depth, lens thickness)
8 months
Study Arms (1)
Biometric measurement repeatability
OTHERBiometric measurements will be performed in all patients
Interventions
Three biometric measurements will be performed with 3 devices for all the patients included
Three biometric measurements will be performed with 3 devices for all the patients included
Three biometric measurements will be performed with 3 devices for all the patients included
Eligibility Criteria
You may qualify if:
- years old or above
- age-related cataract
You may not qualify if:
- patients with dense cataract or corneal pathology that would significantly influence biometric measurements
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140, Austria
Related Publications (1)
Fisus AD, Hirnschall ND, Ruiss M, Pilwachs C, Georgiev S, Findl O. Repeatability of 2 swept-source OCT biometers and 1 optical low-coherence reflectometry biometer. J Cataract Refract Surg. 2021 Oct 1;47(10):1302-1307. doi: 10.1097/j.jcrs.0000000000000633.
PMID: 33770018DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, Prof
VIROS, Hanusch Hospital Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of the Ophthalmology Department, and Principal Investigator
Study Record Dates
First Submitted
January 31, 2020
First Posted
February 5, 2020
Study Start
November 25, 2019
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
October 1, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share