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

• Status: Unknown status
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meir Medical Center
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

Non-pregnant adults, excluding individuals with legal misjudgement, with moderate-severe Dry Eye Syndrome (DES).

Moderate-severe DES will be defined by the following criteria:

1. Schirmer test without anesthesia < 7 mm / 5 seconds AND

2. One or more of the following (a-c):

1. OSDI score >20

2. Positive fluorescein staining (staining degree 1 in one of the eyes, where 0=no staining, 3=very significant staining)

3. Tear Break-Up Time (TBUT) <= 8 seconds in one of the eyes.

Exclusion Criteria:

1. Disagreement to participate in the trial

2. Stevens-Johnson syndrome

3. Post-burn ocular injury

4. Chronic ocular diseases other that DES requiring topical treatment

5. Ocular herpes simplex disease

6. Persistent ocular inflammation or infection

7. Active blepharitis or blepharitis defined more severe than mild

8. Intraocular procedure less than 3 months prior to participation in the trial

9. Punctal plugs in one of the eyes

10. Subepithelial corneal scars

11. Neurotrophic cornea

12. Contact lens use in the 3 months prior to participation in the trial

13. Current topical treatment with Cyclosporine A

14. Previous refractive surgery

15. Keratoconus patients