Prevalence of Blepharitis Signs and Symptoms Amongst Patients With Age Related Macular Degeneration .

1. Prevalence of Blepharitis Signs and Symptoms Amongst Patients With Age Related Macular Degeneration. Rishi P. Singh, MD Cole Eye Institute, Cleveland Clinic Foundation, Cleveland Ohio Financial Disclosure: The author is a consultant to Oraya Therapeutics, Inspire, Alcon, and Genentech. 1

2. Purpose • It has been recommended that prior to intravitreal injections, the ophthalmologist should identify and treat patients with comorbidities that predispose to endophthalmitis, specifically patients with active blepharitis. • However, little is known on the rates of blepharitis within this treatment population. • The purpose of this study is to determine the rates of anterior blepharitis amongst patients eligible for intravitreal injection for age related macular degeneration. 2

3. Methods • In this IRB approved study, patients with both dry and wet AMD were assessed for frequency of common ocular surface symptoms associated with blepharitis with a self-reported survey. • The patients scored their responses on a scale of 0-4 (0-no symptoms, 1-mild, 2-moderate, 3-severe, 4-very severe). • The masked investigator also performed a clinical examination scored both eyes for signs of blepharitis. 3

4. Methods: Self Reported Patient Questions • Eyelid itching: Do your eyelids feel itchy? • (0) None: My eyelids do not feel itchy. • (1) Mild: Once in a while, my eyelids feel slightly itchy, but I do not have a desire to rub them. • (2) Moderate: Occasionally, my eyelids feel itchy, and I need to rub them. • (3) Severe: It is difficult to relieve the sensation of itchiness even when I rub my eyelids. • (4) Very severe: I have unbearable eyelid itching with an irresistible urge to rub my eyelids. • Foreign body sensation/sandiness, grittiness: Do you feel like there’s something sandy or gritty in your eye? • (0) None: My eyes do not feel sandy or gritty. • (1) Mild: I am aware of the surface of my eyes once in a while. • (2) Moderate: My eyes feel like there is something small in them occasionally. • (3) Severe: My eyes feel like there is something large or gritty in them. • (4) Very severe: I am unable to open my eyes due to feeling of a foreign body in myeyes. 4

5. Methods: Self Reported Patient Questions • Ocular dryness: Are your eyes feeling dry? • (0)None: My eyes do not feel dry. • (1)Mild: I am aware of dryness to the point where I have to blink to feel better • (2)Moderate: I am aware of dryness to the point where I desire to use artificial tears occasionally. • (3)Severe: I am aware of dryness to the point where I desire to use artificial tears frequently. • (4)Very severe: I am aware of dryness, to the point where I always desire to use artificial tears. • Ocular burning or pain: Are your eyes burning or painful? • (0)None: My eyes do not burn or ache. • (1)Mild: I am aware of the surface of my eyes; they mildly burn or ache. • (2)Moderate: I feel my eyes are burning, but still tolerable • (3)Severe: My eyes feel throbbing or fiery due to burning/pain. • (4)Very severe: I am unable to open my eyes due to burning/pain. 5

6. Methods: Masked Investigator Scoring Severity • Plugging of the meibomian gland (in the middle part of lower lid, n=10) • (0) Normal: Clear orifices of meibomian glands in the middle part of lower lid (n=0) • (1) Mild: Less than 1/3 of orifices but at least one contain turbid secretions (n=1-3) • (2) Moderate: Between 1/3 and 2/3 of orifices contain turbid secretions (n=4-6) • (3) Severe: More than 2/3 of orifices but not all contain turbid secretions (n=7-9) • (4) Very severe: All orifices plugged with turbid or coagulated secretions (n=10) • Secretion expressed from the meibomian gland • (0) Normal: Minimal clear, oily secretion • (1) Mild: Cloudy secretion • (2) Moderate: Granular secretion • (3) Severe: Paste-like secretion • (4) Obstructed: No expressible secretion 6

7. Methods: Masked Investigator Scoring Severity • Lid debris (collarettes, clumps/strands) • (0)Normal: Clear eyelid margin • (1)Mild: Occasional fragment, 1-5 collarettes • (2)Moderate: Few fragments, 6-20 collarettes • (3)Severe: Many fragments, 21-40 collarettes • (4)Very severe: Clumps/strands, >40 collarettes • Eyelid margin erythema • (0) Normal: Normal age-related redness and vasculature. • (1) Mild:Slightly dilated blood vessels; vessels colored pink; present in the middle 2/3 section of the lower eyelid margin. • (2) Moderate: More apparent dilation of blood vessels; vessel color more intense, whole margin of the eyelid is involved. • (3)Severe: Increased vascularity of the eyelid margin, numerous and obvious dilated blood vessels, deep red in color, whole margin of the eyelid is involved. • (4)Very severe: Clearly increased confluent vascularity of the eyelid margin; large, numerous dilated blood vessels characterized by deep red color, whole margin of the eyelid is involved. 7

8. Results: Demographics • 50 patients: • Sex: 21 male, 29 female • Age: 78.1 ± 8.48 years • AMD Status: • Non-exudative (n = 21) • Exudative (n = 29) • 32% had a history of dry eye or blepharitis prior to examination • 26% had a history of rosacae. 8

9. Results: Symptoms of Blepharitis by Patient Reported Survey Example: Eyelid Itching • Patients reported the following symptoms: • Eyelid itching – 1.2 • Foreign body sensation – 1.1 • Ocular dryness - 1.2 • Ocular burning/pain – 1.1 • Swollen heavy lids – 0.8. 9

10. Results: Signs of Blepharitis • Masked Physician Recorded Symptoms: • Lid debris – 1.5 • Eyelid margin erythema – 1.7 • Plugging of meibomian glands -1.5 • Secretion expressed from the meibomian gland – 1.9. Example: Lid Debris 10

11. Results: • Self-reported patient surveys and masked investigator examinations demonstrated similar-high prevalence of blepharitis (86% and 94% respectively). • Fourteen percent of total patients reported no symptoms, and six percent had no clinical signs of blepharitis. • Most patients had mild to moderate disease. • The incidences were 50% and 36% for mild, 32% and 50% for moderate, and only 4% and 8% for severe symptoms and signs of blepharitis, respectively. • Self-reported symptom scores were generally lower than clinical examination scores. • The study strengths include that it was a prospective study, masked investigator, and patients were randomly chosen from AMD panel. • The study weaknesses include that it was performed at a single site, by a single investigator. Adding photo grading by masked individuals may have improved the scientific method. 11

12. Conclusions: • The prevalence of blepharitis is very high in the AMD patient population who may require frequent intravitreal injections. • Prompt evaluation and control of blepharitis and close adherence to intravitreal injection guidelines may be suggested to minimize possible complication with endophthalmitis. 12