Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02424266
Other study ID # MMC-0166-13
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 1, 2015
Last updated April 22, 2015
Start date April 2015
Est. completion date June 2016

Study information

Verified date April 2015
Source Meir Medical Center
Contact Noa Geffen, MD
Phone +972-9-7472427
Email noatal1122@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

The purpose of this study is to investigate the ability of an imaging device, developed by AdOM Advanced Optical Technologies Ltd. ("AdOM"). AdOM has produced an imaging device based on a standard fundus camera that uses white light, and as combined with new algorithms allows for a new reconstruction of three-dimensional images. The materials from which the Medical Instrumentation and Device are comprised are optical components (lenses), a broadband light source power, mechanical engines, beam splitters, and optical filters. The device will in addition contain camera sensors and a spectral detector. These elements are linked to a computer which includes control software and a user interface. The device allows a three-dimensional imaging of the ocular tissues, specifically the tear film layers and the retinal layers.

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.

The aqueous layer of the tear layer thickness is expected to be measured at an accuracy level of approximately one nanometer. All values will be measured over time and thus it will be possible to deduce the breakup time of the tear layer and the evaporation rate. It is possible that information will also be provided on the mucin layer and its level of sharpness.

Using the device will include the following steps:

1. Resting the head and fixing it with the assistance of the chin and forehead rests.

2. Locating and focusing the device on the cornea or retina with the help of the examiner.

3. Identifying the retinal and vitreous layers and pressing to start measurement or, alternatively:

4. Identifying the tear film layers and pressing to start the measurement.

5. Pressing on the button to end the measurement. The expected measurement duration is 20 to 70 seconds. Analysis of the returned light will describe at each second the thickness of the layers and the continuity of the surface.

Study population:

A total of 20 healthy patients. A total of 40 adult male or female patients with moderate-to-severe KCS or DES.

Conduct of the Study:

This is a case-control, non-randomized observational study. The study will include two visits: a screening visit and a study visit.

During the screening visit the patients will sign the informed consent form and a full medical history will be recorded. All ocular signs and symptoms will be evaluated and a full biomicroscopic examination will be performed. Disease activity will be assessed using the Dry Eye Symptom Score (DESS), Schirmer Test (ST), tear meniscus height (TM), tear break-up time (BUT), and fluorescein staining (FS).

The second visit will be scheduled up to 4 weeks after the screening visit. During the second visit (the photography session), all ocular signs and symptoms will be evaluated and a full biomicroscopic examination will be performed. Disease activity will be assessed using the Dry Eye Symptom Score (DESS), Schirmer Test (ST), tear meniscus height (TM), tear break-up time (BUT), and fluorescein staining (FS).

The tear film layer will be photographed by the investigational device and the participation of the volunteers in the study will end with the end of the photography session.

Time frame: participants will be followed for the duration of their participation in the study which is expected to be up to 4 weeks.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Age >/= 18 years Healthy controls - without dry eyes

Patients with a diagnosis of moderate-to-severe KCS as defined by all of the following:

1. The presence of at least one ocular symptom of dryness scored at > 2 (where 0 = none and 4 = very severe /interferes with normal activities)

2. Positive Schirmer test (ST without anesthesia) < 7 mm/5 min in either eye

3. Positive fluorescein stainig (FS), defined as a corneal punctate fluorescein staining score of > 1 in either eye, where 0 = none and 3 = severe.

Exclusion Criteria:

1. Stevens-Johnson Syndrome

2. Post-burn ocular injury

3. Chronic ocular disease other than KCS requiring topical treatment

4. Ocular herpes simplex virus infection

5. Use of contact lenses

6. Persistent Intraocular Inflammation or Infection

7. Active blepharitis of greater than mild degree

8. Recent surgical occlusion of the lacrimal puncta

9. Subepithelial cornea scarring

10. Anesthetic or neurotrophic corneas.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Imaging capabilities (field of view, resolution) field of view, measured in millimeters
resolution measured in line per millimeters
On sight No
Secondary Tear film measurements (lipid layer thickness, aqueous layer thickness) lipid layer thickness measured in microns
aqueous layer thickness measured in microns
on sight No
See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1