Dry Eye
Conditions
Keywords
meibomian gland dysfunction
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.
Interventions
DEVICEintense pulsed light
Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
Sponsors
Toyos Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patient were enrolled in the study if they had visible signs of upper lid meibomian gland dysfunction and persistent dry eye symptoms and pain despite treatment with conservative dry eye therapies.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive Tear Break up Time (TBUT) | 2 weeks | average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Visual Analog Scale Pain Over Last 24 Hours | 24 hours | measure (in millimeters) of pain on scale of minimum of 0 mm(no pain)- maximum of 100mm (maximal pain and worse outcome) |
| Ocular Discomfort Frequency Assessment on Visual Analog Scale | 24 hours | scale of minimum of 0 mm (no episodes)-maximum of 100 mm (constant painful episodes and worse outcome) frequency of dry eye pain episodes |
| Measure of Visual Analog Scale Pain | 2 weeks | measure of pain since last visit on scale of minimum of 0 mm (no pain)- maximum of 100 mm (maximal pain and worse outcome) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Upper Eyelid Meibomian Gland Dysfunction |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 64.05 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 13 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Upper Eyelid Meibomian Gland Dysfunction | Non-invasive Tear Break up Time (TBUT) | TBUT OD (right eye) | 3.9 seconds |
| Upper Eyelid Meibomian Gland Dysfunction | Non-invasive Tear Break up Time (TBUT) | TBUT OS (left eye) | 4.0 seconds |
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)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Upper Eyelid Meibomian Gland Dysfunction | Measure of Visual Analog Scale Pain | 26.93 millimeters | Standard Deviation 0.01 |
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)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Upper Eyelid Meibomian Gland Dysfunction | Measure of Visual Analog Scale Pain Over Last 24 Hours | 65.42 millimeters | Standard Deviation 0.01 |
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
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Upper Eyelid Meibomian Gland Dysfunction | Ocular Discomfort Frequency Assessment on Visual Analog Scale | 28.27 millimeters | Standard Deviation 0.01 |