N/A N=19 Treatment

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

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT03658811 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Non-invasive Tear Break up Time (TBUT) — 3.9; 4.0 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: intense pulsed light (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Toyos Clinic
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Non-invasive Tear Break up Time (TBUT)	3.9; 4.0	—
SECONDARY Measure of Visual Analog Scale Pain Over Last 24 Hours	65.42	—
SECONDARY Ocular Discomfort Frequency Assessment on Visual Analog Scale	28.27	—
SECONDARY Measure of Visual Analog Scale Pain	26.93	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03658811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.