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

NCT ID: NCT03403023

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2018-12-30

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 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.

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 quantity and quality of the tear film. Lack of timely treatment can lead to corneal surface damage, pain, infection and vision disturbances. However, effective treatment of the disease can lead to a significant improvement in patients' quality of life and improvement in visual acuity.

Conventional treatment modalities focus mainly on lubricating eye drops, but these do not treat the pathophysiologic cause which is the inflammatory process evolving on the ocular surface. Topical Cyclosporine 0.05% (Restasis®) is an anti-inflammatory drug which is the most recommended treatment option for patients with moderate-severe DES who failed conservative treatment. It has been proven to be an effective and safe treatment modality for DES patients, improving tear production, tear film stabilization and slowing disease progression.

The primary modalities for diagnosis and follow-up of DES patients today are manual and require clinician skill and experience. Moreover, current diagnosis modalities are subjective, examiner-based and are not easily reproducible. This raises the need for new diagnosis and follow-up modalities with higher resolution, precision and reproducibility qualities to allow more effective diagnosis and assessment of disease severity and well as assessment of disease progression over time.

AdOM - Advanced Optical Methods produced a Tear Film Imager, a modality based on a standard camera, using white light to image the tear film up to a resolution of 0.1 micrometers. This allows imaging of the individual tear film layers, a property currently not enabled by advanced OCT imaging modalities in use today (yielding a maximum resolution of 2.5 micrometers, thus now allowing imaging of individual tear film layers). In addition, this modality functions using full field imaging rather than raster scanned imaging, thus allowing a wide, full image of the scanned area.

The purpose of the current study is to assess the usage of the TFI in the follow-up of DES patients with moderate-severe disease treated with topical Cyclosporine 0.05%. In our previous study we found that the TFI yields high resolution tear film images, presenting significant differences between healthy and DES eyes. In this study we wish to examine the effects of topical Cyclosporine 0.05% on the tear film and assess the tear film before and after treatment. We believe this can help us better understand the effects of both the disease and the treatment on the tear film, thus allowing more effective diagnosis and treatment for future DES patients.

Conditions

Dry Eye Syndrome; Tear Film Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

DES treated patients

This single group of patients is imaged by the Tear Film Imager (TFI) device before and after treatment with Restasis, the treatment indicated for their condition.

Group Type: EXPERIMENTAL

Tear Film Imager

Intervention Type: DEVICE

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).

Restasis

Intervention Type: DRUG

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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

TFI; Ophthalmic Cyclosporine A 0.05%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

segev fani

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fani Segev, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology department, MeirMC, Israel

Central Contacts

Yael Yohai Patael, M.D.

Role: CONTACT

yael.yohai@gmail.com

+972544914544

Fani Segev, M.D.

Role: CONTACT

fsegev@netvision.net.il

+972526995044

References

Stonecipher K, Perry HD, Gross RH, Kerney DL. The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca. Curr Med Res Opin. 2005 Jul;21(7):1057-63. doi: 10.1185/030079905X50615.

Reference Type: BACKGROUND

PMID: 16004673 (View on PubMed)

Pflugfelder SC. Anti-inflammatory therapy of dry eye. Ocul Surf. 2003 Jan;1(1):31-6. doi: 10.1016/s1542-0124(12)70005-8.

Reference Type: BACKGROUND

PMID: 17075627 (View on PubMed)

Other Identifiers

0178-16-MMC

Identifier Type: -

Identifier Source: org_study_id