Three Dimension Tomography of Eye Structures by White Light Imaging Device

NCT02424266 | Unknown

• 1 other identifier: MMC-0166-13
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the ability of an imaging device, developed by AdOM Advanced Optical Technologies Ltd. ("AdOM"). The device allows a three-dimensional imaging of the ocular tissues, specifically the tear film layers and the retinal layers. The device is based on the use of white light. In this initial study, the device will be used to assess the tear film which coats the corneal surface in healthy subjects as well as in moderate-to-severe Keratoconjunctivitis Sicca (KCS) or Dry Eye Syndrome (DES). The ability of the device to assess the retinal layers will be evaluated in the second phase of the study.

Conditions

Healthy Subjects; Moderate to Severe Keratoconjunctivitis Sicca (KCS); Dry Eye Syndrome (DES)

Keywords

Tear film; Imaging; Tomogrophy; dry eye

Outcome Measures

Primary Outcomes (1)

• Safety (Ocular symptoms)

  Ocular symptoms, including - I. pain (graded as 0-none, 1- mild discomfort, 2-moderate pain, 3- severe pain, 4- very severe), II. burning (graded as 0-none, 1- mild , 2-moderate, 3- severe, 4- very severe), itching (graded as 0-none, 1- mild , 2-moderate, 3- severe, 4-very severe) 2. Red eye (graded as 0-none, 1- mild , 2-moderate, 3- severe, 4- very severe)

  One month

Secondary Outcomes (2)

• Imaging capabilities (field of view, resolution)

  On sight

• Tear film measurements (lipid layer thickness, aqueous layer thickness)

  on sight

Study Arms (2)

Healthy subjects

None invasive imaging of the tear film for subjects with no eye disease

Device: None invasive imaging of the tear film (AdOM)

keratoconjunctivits sicca (KCS) and Dry Eye Syndrome (DES)

None invasive imaging of the tear film for KCS and DES patients as confirmed by a cornea specialist

Device: None invasive imaging of the tear film (AdOM)

Interventions

None invasive imaging of the tear film (AdOM) DEVICE

White light tomography imaging

Healthy subjects; keratoconjunctivits sicca (KCS) and Dry Eye Syndrome (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 healthy subject with no ocular disease 40 subjects with moderate to severe keratoconjunctivitis sicca or dry eye syndrome

You may qualify if:

• Age \>/= 18 years Healthy controls - without dry eyes
• Patients with a diagnosis of moderate-to-severe KCS as defined by all of the following:
• The presence of at least one ocular symptom of dryness scored at \> 2 (where 0 = none and 4 = very severe /interferes with normal activities)
• Positive Schirmer test (ST without anesthesia) \< 7 mm/5 min in either eye
• Positive fluorescein stainig (FS), defined as a corneal punctate fluorescein staining score of \> 1 in either eye, where 0 = none and 3 = severe.

You may not qualify if:

• Stevens-Johnson Syndrome
• Post-burn ocular injury
• Chronic ocular disease other than KCS requiring topical treatment
• Ocular herpes simplex virus infection
• Use of contact lenses
• Persistent Intraocular Inflammation or Infection
• Active blepharitis of greater than mild degree
• Recent surgical occlusion of the lacrimal puncta
• Subepithelial cornea scarring
• Anesthetic or neurotrophic corneas.

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Noa Geffen, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noa Geffen, MD

CONTACT

+972-9-7472427; noatal1122@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 23, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: April 23, 2015

Record last verified: 2015-04