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

Dry Eye Clinical Trial

Official title:

Evaluation of the Safety and Efficacy of Intense Pulse Light Treatment With Meibomian Gland Expression of Upper Eyelids for Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658811
• Other study ID #: TCLum-001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: December 2018
• Source: Toyos Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 31, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• intense pulsed light
Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose

Locations

Country	Name	City	State
United States	Toyos Clinic	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Toyos Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive Tear Break up Time (TBUT)	average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up	2 weeks
Secondary	Measure of Visual Analog Scale Pain Over Last 24 Hours	measure (in millimeters) of pain on scale of minimum of 0 mm(no pain)- maximum of 100mm (maximal pain and worse outcome)	24 hours
Secondary	Ocular Discomfort Frequency Assessment on Visual Analog Scale	scale of minimum of 0 mm (no episodes)-maximum of 100 mm (constant painful episodes and worse outcome) frequency of dry eye pain episodes	24 hours
Secondary	Measure of Visual Analog Scale Pain	measure of pain since last visit on scale of minimum of 0 mm (no pain)- maximum of 100 mm (maximal pain and worse outcome)	2 weeks