Repeatability and Reproducibility of the ArcScan Insight 100 VHF Digital Ultrasound

NCT02519985 | Suspended DMC

• 1 other identifier: LoVC-005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the repeatability and reproducibility of corneal (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment measurements using the ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.

Conditions

Corneal Thickness Measurement; Epithelial Thickness Measurement; Anterior Eye Segment Measurements

Keywords

VHF digital ultrasound; Corneal thickness; Epithelial thickness; Angle diameter; Sulcus diameter; Anterior chamber depth; Repeatability; Reproducibility

Outcome Measures

Primary Outcomes (1)

• Repeatability of ArcScan Insight 100 corneal scans in normal eyes (standard deviation)

  The standard deviation of 5 repeated measurements for corneal thickness, epithelial thickness, and stromal thickness in normal eyes with no previous corneal surgery

  1 day

Secondary Outcomes (5)

• Reproducibility of ArcScan Insight 100 corneal scans in normal eyes (between-operator standard deviation)

  1 day

• Repeatability of ArcScan Insight 100 anterior segment scans in normal eyes (standard deviation)

  1 day

• Reproducibility of ArcScan Insight 100 anterior segment scans in normal eyes (between-operator standard deviation)

  1 day

• Repeatability of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (standard deviation)

  1 day

• Reproducibility of ArcScan Insight 100 corneal scans in eyes after corneal laser refractive surgery (between-operator standard deviation)

  1 day

Study Arms (1)

Repeatability and Reproducibility of ArcScan Insight 100

EXPERIMENTAL

For repeatability and reproducibility in normal eyes (n=20): Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the first operator. After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea and anterior segment will be performed by the second operator. For repeatability and reproducibility in eyes after laser refractive surgery (n=20): Firstly, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the first operator. After a break of about 30 minutes, 5 consecutive repeated ArcScan Insight 100 scans of the cornea will be performed by the second operator.

Device: ArcScan Insight 100 very high-frequency digital ultrasound

Interventions

ArcScan Insight 100 very high-frequency digital ultrasound DEVICE

The ArcScan Insight 100 VHF digital ultrasound scanner that 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: VHF digital ultrasound

Repeatability and Reproducibility of ArcScan Insight 100

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 repeatability and reproducibility phase using normal eyes of the study:
• Eyes with no ocular pathology
• Eyes with no previous ocular or corneal surgery
• For the repeatability and reproducibility phase using post-LASIK eyes of the study:
• Eyes between 3 and 9 months after LASIK or SMILE
• For the comparison of ArcScan Insight 100 VHF digital ultrasound with RTVue OCT
• Either eyes before or after corneal refractive surgery

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

Sponsors & Collaborators

• London Vision Clinic: lead
• Arcscan, Inc.: collaborator

Study Sites (1)

London Vision Clinic

London, W1G 7LA, United Kingdom

Location

Related Publications (5)

• Reinstein DZ, Silverman RH, Raevsky T, Simoni GJ, Lloyd HO, Najafi DJ, Rondeau MJ, Coleman DJ. Arc-scanning very high-frequency digital ultrasound for 3D pachymetric mapping of the corneal epithelium and stroma in laser in situ keratomileusis. J Refract Surg. 2000 Jul-Aug;16(4):414-30. doi: 10.3928/1081-597X-20000701-04.

  PMID: 10939721 BACKGROUND

• Paul T, Lim M, Starr CE, Lloyd HO, Coleman DJ, Silverman RH. Central corneal thickness measured by the Orbscan II system, contact ultrasound pachymetry, and the Artemis 2 system. J Cataract Refract Surg. 2008 Nov;34(11):1906-12. doi: 10.1016/j.jcrs.2008.07.013.

  PMID: 19006737 BACKGROUND

• Ursea R, Feng M, Urs R, RoyChoudhury A, Silverman RH. Comparison of artemis 2 ultrasound and Visante optical coherence tomography corneal thickness profiles. J Refract Surg. 2013 Jan;29(1):36-41. doi: 10.3928/1081597X-20121126-01. Epub 2012 Nov 30.

  PMID: 23205905 BACKGROUND

• Ogbuehi KC, Osuagwu UL. Repeatability and interobserver reproducibility of Artemis-2 high-frequency ultrasound in determination of human corneal thickness. Clin Ophthalmol. 2012;6:761-9. doi: 10.2147/OPTH.S31690. Epub 2012 May 21.

  PMID: 22693418 BACKGROUND

• Pinero DP, Plaza AB, Alio JL. Anterior segment biometry with 2 imaging technologies: very-high-frequency ultrasound scanning versus optical coherence tomography. J Cataract Refract Surg. 2008 Jan;34(1):95-102. doi: 10.1016/j.jcrs.2007.08.033.

  PMID: 18165088 BACKGROUND

Study Officials

• Dan Z Reinstein, MD MA

  London Vision Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 11, 2015
• Study Start: November 1, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

GB (1)