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Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy

NCT03403023 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-18

No results posted yet for this study

Summary

Dry Eye Syndrome (DES) is a disease affects the production and stability of the tear film, leading to vision disturbances and a major decrease in quality of life. The most recommended treatment for moderate-severe DES today which failed conservative therapy with lubricating eye drops is topical Cyclosporine 0.05% (Restasis®).

The Tear Film Imager (TFI) is a novel imaging modality designed for visualization of the individual tear film layers up to a resolution of 0.1 micrometers, a property not enabled by any other imaging modality for this indication to date.

In this study we wish to assess the effects of topical Cyclosporine 0.05% on the tear film using the TFI. In our previous study we found this modality yields high resolution images of the tear film, yielding significant differences between healthy and diseased (DES) eyes. We believe the TFI will improve quality of assessment and follow-up of DES patients, allowing more effective diagnosis and treatment of this disease in the future.

Conditions

  • Dry Eye Syndrome
  • Tear Film Insufficiency

Interventions

DEVICE

Tear Film Imager

The TFI is an imaging device based on standard camera that uses white light to image the tear film in an ultra high resolution. DES patients in this study will be imaged before and 3 months after initiation of treatment with Restasis (the treatment indicated for their condition).

DRUG

Restasis

Restasis therapy is given to all of the patients as indicated for moderate-severe DES. TFI imaging is performed before and 3 months after initiation of therapy.

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Fani Segev, M.D. · Ophthalmology department, MeirMC, Israel

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2018-05-30
Completion
2018-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03403023 on ClinicalTrials.gov