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Recruiting NCT05759780

OCT Vibrography for Biomechanical Properties of Tissues

No phase Interventional Cornea Skin Diseases Gingival Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optical imaging of the tissues.
Who it may be relevant to
Registry conditions: Cornea, Skin Diseases, Gingival Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues

Overview

The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo.

Detailed description

The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo. The investigators aim to establish baseline data in healthy subjects, compare elastic moduli in different tissue types, and measure differences in elastic moduli between keratoconus and normal eyes. If successful, this project will provide useful, previously inaccessible elastic parameters and advance the investigators' understanding of the relationship between the bulk mechanical properties and the microstructure of the human tissue in vivo. This information can ultimately be used to improve the diagnosis and treatment of keratoconus, inflammatory skin diseases, and inflammatory gingiva diseases. More broadly, the technologies developed in this project will have relevance to other potential applications beyond the tissues in this research study.

Interventions

  • Device Optical imaging of the tissues
    OCT vibrography

Primary outcome measures

  • Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device. [Time frame: 1 year]

Eligibility criteria

Group 1:

Inclusion criteria

  • Subjects with healthy eyes (age 18 - 75, N = 50)

Exclusion criteria

  • Subjects with history of eye diseases, and previous eye surgeries.
  • Subjects with diabetes, glaucoma family history
  • Subjects allergic to anesthetic eyedrop, especially proparacaine
  • Subjects with severe allergy
  • Subjects who have difficulty biting
  • Subjects who have recurrent corneal erosion

Group 2:

Inclusion criteria

  • Subjects with healthy skin (age 18 - 75, N = 10)

Exclusion criteria

  • Subjects with open cuts/sores on the skin, skin infection, or any contagious skin condition

Group 3:

Inclusion criteria

  • Subjects with healthy gingiva (age 18 - 75, N = 10)

Exclusion criteria

  • Subjects with open cuts/sores on the gingiva, gingiva infection, or any contagious gingiva condition

Group 4:

Inclusion criteria

  • Mild or moderate keratoconus subjects (age 18 - 40, N = 20)

Exclusion criteria

  • Subjects with K-max above 60 diopters (Pentacam imaging) are excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT05759780 · 2023P000338

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗