NCT03473847

Brief Summary

The purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT, and ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
4.4 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

March 8, 2018

Last Update Submit

April 19, 2022

Conditions

Corneal Thickness MeasurementEpithelial Thickness MeasurementLASIK Flap Thickness MeasurementSMILE Cap Thickness Measurement

Keywords

VHF digital ultrasoundOptical coherence tomographyCorneal thicknessEpithelial thicknessLASIKSMILE

Outcome Measures

Primary Outcomes (10)

  • Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in normal eyes (standard deviation)

    The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery

    10 minutes (5 minutes per observer)

  • Repeatability and reproducibility of RTVue OCT corneal scans in normal eyes (standard deviation)

    The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery

    10 minutes (5 minutes per observer)

  • Repeatability and reproducibility of MS-39 OCT corneal scans in normal eyes (standard deviation)

    The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery

    10 minutes (5 minutes per observer)

  • Repeatability and reproducibility of Insight 100 VHF digital ultrasound corneal scans in normal eyes (standard deviation)

    The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in normal eyes with no previous corneal surgery

    30 minutes (15 minutes per observer)

  • Repeatability and reproducibility of Cirrus HD OCT 5000 corneal scans in post-op eyes (standard deviation)

    The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery

    10 minutes (5 minutes per observer)

  • Repeatability and reproducibility of RTVue OCT corneal scans in post-op eyes (standard deviation)

    The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery

    10 minutes (5 minutes per observer)

  • Repeatability and reproducibility of MS-39 OCT corneal scans in post-op eyes (standard deviation)

    The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery

    10 minutes (5 minutes per observer)

  • Repeatability and reproducibility of Insight 100 VHF digital ultrasound corneal scans in post-op eyes (standard deviation)

    The within-observer standard deviation (repeatability) and between-observer standard deviation (reproducibility) calculated by ANOVA for 5 repeated measurements by two observers of corneal thickness and epithelial thickness in eyes between 3 and 9 months after corneal laser refractive surgery

    30 minutes (15 minutes per observer)

  • Difference in corneal thickness measurements between Cirrus HD OCT 5000, RTVue OCT, MS-39 OCT, and Insight 100 VHF digital ultrasound in normal eyes

    The difference between each pair of devices for measurements of corneal thickness and epithelial thickness in eyes with no previous ocular surgery.

    20 minutes for all four scans

  • Difference in corneal thickness measurements between Cirrus HD OCT 5000, RTVue OCT, MS-39 OCT, and Insight 100 VHF digital ultrasound in post-op eyes

    The difference between each pair of devices for corneal thickness, epithelial thickness and interface thickness in eyes between 3 and 9 months after corneal laser refractive surgery

    20 minutes for all four scans

Study Arms (4)

Repeatability and Reproducibility - Normal eyes

EXPERIMENTAL

This arm will include 20 eyes of 20 patients with no previous ocular surgery. The research participant will be scanned a number of times using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). The scan sequence will be undertaken on a single day as follows: 1. 5 consecutive repeated scans of the cornea will be performed by the first operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). 2. There will be a break of about 30 minutes. 3. 5 consecutive repeated scans of the cornea will be performed by the second operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set).

Device: ArcScan Insight 100 very high-frequency digital ultrasoundDevice: Carl Zeiss Meditec Cirrus HD OCT 5000Device: Optovue RTVue OCTDevice: CSO MS-39 OCT

Repeatability and Reproducibility - Post-op eyes

EXPERIMENTAL

This arm will include 20 eyes of 20 patients between 3 and 9 months after corneal laser refractive surgery. The research participant will be scanned a number of times using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). The scan sequence will be undertaken on a single day as follows: 1. 5 consecutive repeated scans of the cornea will be performed by the first operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set). 2. There will be a break of about 30 minutes. 3. 5 consecutive repeated scans of the cornea will be performed by the second operator using each of the four devices (expected total time approximately 5 minutes for each OCT scan set and 15 minutes for the Insight 100 scan set).

Device: ArcScan Insight 100 very high-frequency digital ultrasoundDevice: Carl Zeiss Meditec Cirrus HD OCT 5000Device: Optovue RTVue OCTDevice: CSO MS-39 OCT

Comparison between devices - Normal eyes

EXPERIMENTAL

This arm will include 101 eyes of 101 patients with no previous ocular surgery. The research participant will be scanned once using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). Expected total time approximately 20 minutes to complete all four scans.

Device: ArcScan Insight 100 very high-frequency digital ultrasoundDevice: Carl Zeiss Meditec Cirrus HD OCT 5000Device: Optovue RTVue OCTDevice: CSO MS-39 OCT

Comparison between devices - Post-op eyes

EXPERIMENTAL

This arm will include 101 eyes of 101 patients between 3 and 9 months after corneal laser refractive surgery. The research participant will be scanned once using each of the four devices (the Insight 100 VHF digital ultrasound scanner, the Cirrus HD OCT 5000, the RTVue OCT, and the MS-39 OCT). Expected total time approximately 20 minutes to complete all four scans.

Device: ArcScan Insight 100 very high-frequency digital ultrasoundDevice: Carl Zeiss Meditec Cirrus HD OCT 5000Device: Optovue RTVue OCTDevice: CSO MS-39 OCT

Interventions

ArcScan Insight 100 very high-frequency digital ultrasoundDEVICE

The ArcScan Insight 100 VHF digital ultrasound scanner can measure individual layers within the cornea with very high precision, as well as being able to image the interior of the eye including the chamber between the iris and the cornea, the lens and other structures behind the iris. The ArcScan Insight 100 device is a digital ultrasound scanner, meaning that it uses ultrasound waves to measure parameters of the eye. The Insight examination involves the patient sitting in front of the ultrasound unit and looking through a disposable goggle-like eyepiece at a light source. Warm sterile balanced saline solution (like natural tears) are used to fill the space between the light source and the eye, to allow ultrasound transmission. There is no contact between the instrument and the eye other than being immersed in this water bath.

Also known as: Artemis very high-frequency digital ultrasound
Comparison between devices - Normal eyesComparison between devices - Post-op eyesRepeatability and Reproducibility - Normal eyesRepeatability and Reproducibility - Post-op eyes
Carl Zeiss Meditec Cirrus HD OCT 5000DEVICE

The Cirrus HD OCT 5000 uses high definition spectral domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.

Comparison between devices - Normal eyesComparison between devices - Post-op eyesRepeatability and Reproducibility - Normal eyesRepeatability and Reproducibility - Post-op eyes
Optovue RTVue OCTDEVICE

The Optovue RTVue OCT uses high definition Fourier/spectral domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.

Comparison between devices - Normal eyesComparison between devices - Post-op eyesRepeatability and Reproducibility - Normal eyesRepeatability and Reproducibility - Post-op eyes
CSO MS-39 OCTDEVICE

The CSO MS-39 OCT uses high definition Fourier domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. The MS-39 also includes a Placido topographer within the device to simultaneously obtain a measurement of the shape (curvature) of the front surface of the cornea, which is then combined with the OCT thickness measurement to generate the shape of the back surface of the cornea. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.

Comparison between devices - Normal eyesComparison between devices - Post-op eyesRepeatability and Reproducibility - Normal eyesRepeatability and Reproducibility - Post-op eyes

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only patients who are medically suitable for corneal laser refractive surgery can be included in the study.
  • Subjects should be 21 years of age or older.
  • Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
  • Patient will be able to understand the patient information and willing to sign an informed consent.
  • For the normal eye populations:
  • Eyes with no ocular pathology
  • Eyes with no previous ocular or corneal surgery
  • For the post-op eye populations:
  • Eyes between 3 and 9 months after LASIK or SMILE

You may not qualify if:

  • Previous ocular or corneal surgery (for normal eyes)
  • Patient not being able to tolerate local or topical anesthesia
  • Patient has active conjunctivitis or any active ocular infection or inflammation
  • Patient has a corneal ulcer
  • Patient has an open wound on the corneal epithelium
  • Patient has compromised epithelium (e.g. ≥Grade 3 superficial punctate keratitis)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Vision Clinic

London, W1G 7LA, United Kingdom

Location

Related Publications (4)

  • Reinstein DZ, Archer TJ, Gobbe M, Silverman RH, Coleman DJ. Repeatability of layered corneal pachymetry with the artemis very high-frequency digital ultrasound arc-scanner. J Refract Surg. 2010 Sep;26(9):646-59. doi: 10.3928/1081597X-20091105-01. Epub 2009 Nov 16.

    PMID: 19928698BACKGROUND

  • Reinstein DZ, Yap TE, Archer TJ, Gobbe M, Silverman RH. Comparison of Corneal Epithelial Thickness Measurement Between Fourier-Domain OCT and Very High-Frequency Digital Ultrasound. J Refract Surg. 2015 Jul;31(7):438-45. doi: 10.3928/1081597X-20150623-01.

    PMID: 26186562BACKGROUND

  • Yap TE, Archer TJ, Gobbe M, Reinstein DZ. Comparison of Central Corneal Thickness Between Fourier-Domain OCT, Very High-Frequency Digital Ultrasound, and Scheimpflug Imaging Systems. J Refract Surg. 2016 Feb;32(2):110-6. doi: 10.3928/1081597X-20151223-01.

    PMID: 26856428BACKGROUND

  • Kiraly L, Stange J, Kunert KS, Sel S. Repeatability and Agreement of Central Corneal Thickness and Keratometry Measurements between Four Different Devices. J Ophthalmol. 2017;2017:6181405. doi: 10.1155/2017/6181405. Epub 2017 Mar 5.

    PMID: 28357136BACKGROUND

Study Officials

  • Dan Z Reinstein, MD, MA, FRCOphth

    London Vision Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Scans from 4 devices obtained on the same patient population for comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 22, 2018

Study Start

September 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

No data will be shared with other researchers

Locations

GB(1)