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Repeatability in Measurements of Two ssOCT and One OLCR Biometer

Primary Purpose

Cataract Senile

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
biometric measurement IOLMaster 700
biometric measurement Lenstar LS 700
biometric measurement Anterion Heildelberg
Sponsored by
Prim. Prof. Dr. Oliver Findl, MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract Senile focused on measuring ss-OCT, OLCR, biometry

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 40 years old or above
  • age-related cataract

Exclusion Criteria:

  • 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.

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery (VIROS)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Biometric measurement repeatability

Arm Description

Biometric measurements will be performed in all patients

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 31, 2020
Last Updated
September 30, 2020
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
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1. Study Identification

Unique Protocol Identification Number
NCT04255706
Brief Title
Repeatability in Measurements of Two ssOCT and One OLCR Biometer
Official Title
Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome. ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration. This a prospective observational study that would include patients which attended pre-surgical examination. A written informed consent will be obtained from each patient. Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Lenstar LS 700 and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile
Keywords
ss-OCT, OLCR, biometry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biometric measurement repeatability
Arm Type
Other
Arm Description
Biometric measurements will be performed in all patients
Intervention Type
Device
Intervention Name(s)
biometric measurement IOLMaster 700
Intervention Description
Three biometric measurements will be performed with 3 devices for all the patients included
Intervention Type
Device
Intervention Name(s)
biometric measurement Lenstar LS 700
Intervention Description
Three biometric measurements will be performed with 3 devices for all the patients included
Intervention Type
Device
Intervention Name(s)
biometric measurement Anterion Heildelberg
Intervention Description
Three biometric measurements will be performed with 3 devices for all the patients included
Primary Outcome Measure Information:
Title
Evaluation of repeatability between two ss-OCT and one OLCR biometry device
Description
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)
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 40 years old or above age-related cataract Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof
Organizational Affiliation
VIROS, Hanusch Hospital Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33770018
Citation
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. Erratum In: J Cataract Refract Surg. 2022 Jun 1;48(6):750.
Results Reference
derived

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Repeatability in Measurements of Two ssOCT and One OLCR Biometer

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