Age-dependency of Cornea Biomechanics Using OCT Vibrography

NCT03230981 | Completed

• 1 other identifier: 2017P000867
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study is to assess the ability of a new optical coherence tomography system to obtain information on biomechanics of the cornea.

Conditions

Cornea

Keywords

biomechanics; cornea; optical coherence tomography; vibrography; brillouin microscopy

Outcome Measures

Primary Outcomes (1)

• Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.

  Frequency and severity of all treatment-related adverse events

  1 year

Secondary Outcomes (1)

• Validation of OCT Vibrography data by means of Brillouin microscopy measurements of the in-vivo cornea

  1 year

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Optical imaging of the cornea in healthy subjects

Device: Optical imaging of the cornea in healthy subjects

Interventions

Optical imaging of the cornea in healthy subjects DEVICE

OCT vibrography and Brillouin microscopy

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between the ages of 18 to 79 years
• Healthy normal subjects with no significant eye disease and no significant refractive errors

You may not qualify if:

• Volunteers with implanted intraocular lenses
• Volunteers with LASIK or any other eye surgery, and monocular volunteers
• Volunteers with restricted mobility, who cannot stand up, walk or sit still on a chair without a back
• Subjects who do not or cannot understand the instructions for imaging
• Subjects with diabetes, glaucoma family history
• Subjects who are pregnant and/or breastfeeding.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Eye and Ear Infirmary: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.

  PMID: 12719068 BACKGROUND

• de Sanctis U, Loiacono C, Richiardi L, Turco D, Mutani B, Grignolo FM. Sensitivity and specificity of posterior corneal elevation measured by Pentacam in discriminating keratoconus/subclinical keratoconus. Ophthalmology. 2008 Sep;115(9):1534-9. doi: 10.1016/j.ophtha.2008.02.020. Epub 2008 Apr 11.

  PMID: 18405974 BACKGROUND

• Li X, Rabinowitz YS, Rasheed K, Yang H. Longitudinal study of the normal eyes in unilateral keratoconus patients. Ophthalmology. 2004 Mar;111(3):440-6. doi: 10.1016/j.ophtha.2003.06.020.

  PMID: 15019316 BACKGROUND

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Seok-Hyun Yun, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 27, 2017
• Study Start: August 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)