Status:
UNKNOWN
Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy
Lead Sponsor:
Meir Medical Center
Conditions:
Dry Eye Syndrome
Tear Film Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 mo...
Detailed Description
Dry Eye Syndrome (DES) is a common eye disease that damages corneal eye surface in approximately 30% of patients who turn to treatment by Ophthalmologists. These diseases derive from changes in the qu...
Eligibility Criteria
Inclusion
- 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:
- Schirmer test without anesthesia \< 7 mm / 5 seconds AND
- One or more of the following (a-c):
- OSDI score \>20
- Positive fluorescein staining (staining degree 1 in one of the eyes, where 0=no staining, 3=very significant staining)
- Tear Break-Up Time (TBUT) \<= 8 seconds in one of the eyes.
Exclusion
- Disagreement to participate in the trial
- Stevens-Johnson syndrome
- Post-burn ocular injury
- Chronic ocular diseases other that DES requiring topical treatment
- Ocular herpes simplex disease
- Persistent ocular inflammation or infection
- Active blepharitis or blepharitis defined more severe than mild
- Intraocular procedure less than 3 months prior to participation in the trial
- Punctal plugs in one of the eyes
- Subepithelial corneal scars
- Neurotrophic cornea
- Contact lens use in the 3 months prior to participation in the trial
- Current topical treatment with Cyclosporine A
- Previous refractive surgery
- Keratoconus patients
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03403023
Start Date
January 30 2018
End Date
December 30 2018
Last Update
January 18 2018
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