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

Demaod

Status

Enrolling

Conditions

Dry Eye Syndromes

Treatments

Device: VR system by Demaod

Study type

Interventional

Funder types

Industry

Identifiers

NCT05741398

CLN 0100

Details and patient eligibility

About

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.

Full 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).

Enrollment

15 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: