Evaluation of Optical System in the Treatment of - Dry Eye Disease

NCT ID: NCT05741398

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-30

Brief Summary

Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.

Detailed Description

Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects.

All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment).

Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).

Conditions

Dry Eye Syndromes

Study Design

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

Study Groups

Demaod VR system tratment

Non-invasive light pulse generated by a non-contacting device for treating the symptoms of dry eyes and MDG.

Group Type: EXPERIMENTAL

VR system by Demaod

Intervention Type: DEVICE

non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG

Interventions

VR system by Demaod

non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18 years and older of any gender or race.
• Provide written informed consent before study participation.
• Willingness and ability to return for all study visits.
• Ocular Surface Disease Index (OSDI) questionnaire and a score of ≥ 23 at the baseline visit.
• Tear break-up time (TBUT) <10 seconds in both eyes.
• Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.

Exclusion:

• History of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year.
• Patients with giant papillary conjunctivitis.
• Patients with punctal plugs or who have had punctal cautery.
• Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
• Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months.
• Aphakic Patients.
• Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
• Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye).
• Active ocular inflammation or history of chronic, recurrent ocular inflammation within 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis).

Criteria:

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Demaod Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Haemek Medical Center

Afula, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Hila Kfir, b.sc

Role: CONTACT

Kfirclinical@gmail.com

0523313350

Facility Contacts

Daniel Briscoe, MD

Role: primary

dr.danielbriscoe@gmail.com

050-4439421

Other Identifiers

CLN 0100

Identifier Type: -

Identifier Source: org_study_id