Intense Pulse Light Treatment With Meibomian Gland Expression of the Upper Eyelids in Dry Eye Disease

NCT ID: NCT03658811

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2018-10-31

Brief Summary

Upper eyelid treatment has not been used with previously described methods of treatment of dry eye disease using intense pulsed light therapy because the upper lids disease was typically not as advanced as lower lid and because direct treatment of the upper lid was not felt to be necessary as each light pulse extended over the entire periorbita even when concentrated on the lower lid.

Detailed Description

Dry eye disease is an under-diagnosed and growing problem. Intense pulsed light has been a proven method of improving the signs and symptoms of meibomian gland dysfunction including lid margin vascularity, meibum viscosity, OSDI mean score and tear break up. This study looks at the safety and effect of treatment of upper lids only to evaluate the safety and efficacy of direct upper lid treatment on the signs and symptoms of dry eye.

Conditions

Dry Eye

Study Design

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

Study Groups

Upper eyelid meibomian gland dysfunction

Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments

Group Type: EXPERIMENTAL

intense pulsed light

Intervention Type: DEVICE

Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose

Interventions

intense pulsed light

Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• subjects older than 18
• cloudy or inspissated meibomian glands in both upper lids
• ocular pain due to dry eye unrelieved by current or prior use of conservative topical dry eye medications including but not limited to over the counter artificial tears, lifitegrast, cyclosporine, or sodium chloride.

Exclusion Criteria

• Patients with eyelid abnormalities
• intense pulsed light treatment within the past year.
• Patients on oral retinoids,
• patients undergoing intraocular surgery within the past year,
• patients with uncontrolled ocular disease,
• Fitzpatrick skin type V or VI,
• neuro-paralysis in the planned treatment area in the past 6 months,
• pre-cancerous lesions in the planned treatment area.
• New topical eye treatments,
• previous expression of meibomian glands,
• legally blind in one eye.

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

Sponsors

Toyos Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toyos Clinic

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TCLum-001

Identifier Type: -

Identifier Source: org_study_id