Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05232214
Status:
UNKNOWN
Last Update Posted:
2022-10-17
First Post:
2022-01-30
Brief Title:
Comparison of Three Swept-source Optical Coherence Biometry Devices in Long and Short Eyes
Sponsor:
Vienna Institute for Research in Ocular Surgery
Organization:
Vienna Institute for Research in Ocular Surgery
Study Overview
Official Title:
Comparison of Three Swept-source Optical Coherence Biometry Devices in Long and Short Eyes
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to compare the agreement and repeatability of ocular biometric parameters obtained using three swept-source optical coherence tomography ss-OCT device Argos IOLMaster 700 and ANTERION
This is a prospective single centre study that would include a number of 50 eyes of 50 patients which attend pre-surgical examination Three measurements per biometry device will be performed on the day of the first eye surgery The measurements will be performed in a randomised fashion with three ss-OCT devices IOLMaster 700 Argos and ANTERION
Inclusion criteria are 40 years or above age-related cataract 20 eyes with AL 220 mm and 30 eyes with AL255 mm
Exclusion criteria are patients with ocular or systemic pathologies that would interfere with the measurements eg dense cataract corneal pathology nystagmus
The main outcome of the study will be the difference Limits of agreement between the devices for the following parameters keratometry Ks Kf Km CCT µm ACD mm LT mm AL mm Secondary outcomes will be repeatability coefficient and coefficient of variation between the three device measurement time for each device and the feasibility for the Argos device
This is a prospective single centre study that would include a number of 50 eyes of 50 patients which attend pre-surgical examination Three measurements per biometry device will be performed on the day of the first eye surgery The measurements will be performed in a randomised fashion with three ss-OCT devices IOLMaster 700 Argos and ANTERION
Inclusion criteria are 40 years or above age-related cataract 20 eyes with AL 220 mm and 30 eyes with AL255 mm
Exclusion criteria are patients with ocular or systemic pathologies that would interfere with the measurements eg dense cataract corneal pathology nystagmus
The main outcome of the study will be the difference Limits of agreement between the devices for the following parameters keratometry Ks Kf Km CCT µm ACD mm LT mm AL mm Secondary outcomes will be repeatability coefficient and coefficient of variation between the three device measurement time for each device and the feasibility for the Argos 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
A previous study reported that the AL differs between adults was due mainly to the difference in vitreous cavity The longer the AL becomes the longer the posterior vitreous body becomes and the Argos defines the vitreous refractive index as 1336 Therefore it is possible that the equivalent refractive index used in the IOLMaster 700 exceeds 1336 Omoto et al showed that the comparison of the arithmetic prediction errors between the Argos and IOLMaster 700 indicated that both biometers showed a myopic trend and the median arithmetic prediction errors were closer to zero with the Argos the longer the AL became this trend became more marked suggesting that the Argos showed a significant hyperopic trend especially with longer ALs
This might show the advantage of using segmental refractive index instead of equivalent refractive index in longer ALs Nevertheless the authors did not include short eyes 22mm and longer AL 32mm thus further studies should be needed
The aim of the study is to compare the agreement and repeatability of AL measurement using three different ssOCT devices in short 225mm and long eyes 255mm
This a prospective randomised observational study that would include patients 42 eyes of 42 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 Argos 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
The order in which the measurements will be performed Anterion IOLMaster 700 or Argos will be randomised using randomisedorg
Patients will be measured 8 weeks -2 weeks postoperatively with the three devices and the postoperative examination will also contain visual acuity autorefraction and subjective refraction
Each patient will receive the same type of lens standard IOL Clareon Alcon Inclusion criteria
Written informed consent
21 years old or above
age-related cataract
AL225 mm or 255 mm long or short eyes Exclusion criteria
patients with dense cataract LOCS grading III or mature cataract
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
Main outcome Limits of agreement 196xSD between the optical biometers for the AL mm data
Secondary outcomes
Subgroup analysis for the refractive outcome SEQ after 8 weeks -2 weeks in short 225mm and long eyes 255mm
Limits of agreement 196xSD between the optical biometers for the following variables keratometry Ks Kf Km CCT µm ACD mm LT mm
Duration seconds of measurement time and total time including data entry
Evaluation of the Barrett and Haigis formulae with the 3 devices mean of actual vs mean of predicted SEQ
Repeatability coefficient within subject standard deviation - SD and coefficient of variation between the three devices
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
A previous study reported that the AL differs between adults was due mainly to the difference in vitreous cavity The longer the AL becomes the longer the posterior vitreous body becomes and the Argos defines the vitreous refractive index as 1336 Therefore it is possible that the equivalent refractive index used in the IOLMaster 700 exceeds 1336 Omoto et al showed that the comparison of the arithmetic prediction errors between the Argos and IOLMaster 700 indicated that both biometers showed a myopic trend and the median arithmetic prediction errors were closer to zero with the Argos the longer the AL became this trend became more marked suggesting that the Argos showed a significant hyperopic trend especially with longer ALs
This might show the advantage of using segmental refractive index instead of equivalent refractive index in longer ALs Nevertheless the authors did not include short eyes 22mm and longer AL 32mm thus further studies should be needed
The aim of the study is to compare the agreement and repeatability of AL measurement using three different ssOCT devices in short 225mm and long eyes 255mm
This a prospective randomised observational study that would include patients 42 eyes of 42 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 Argos 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
The order in which the measurements will be performed Anterion IOLMaster 700 or Argos will be randomised using randomisedorg
Patients will be measured 8 weeks -2 weeks postoperatively with the three devices and the postoperative examination will also contain visual acuity autorefraction and subjective refraction
Each patient will receive the same type of lens standard IOL Clareon Alcon Inclusion criteria
Written informed consent
21 years old or above
age-related cataract
AL225 mm or 255 mm long or short eyes Exclusion criteria
patients with dense cataract LOCS grading III or mature cataract
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
Main outcome Limits of agreement 196xSD between the optical biometers for the AL mm data
Secondary outcomes
Subgroup analysis for the refractive outcome SEQ after 8 weeks -2 weeks in short 225mm and long eyes 255mm
Limits of agreement 196xSD between the optical biometers for the following variables keratometry Ks Kf Km CCT µm ACD mm LT mm
Duration seconds of measurement time and total time including data entry
Evaluation of the Barrett and Haigis formulae with the 3 devices mean of actual vs mean of predicted SEQ
Repeatability coefficient within subject standard deviation - SD and coefficient of variation between the three devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None