The aim of the study is to evaluate the safety and efficacy of radiofrequency treatment for dry eye disease due to meibomian gland dysfunction
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Eligible subjects will receive up to 3 treatments (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment.
Centennial Eye Associates
Aurora, Colorado, United States
Excellent Vision
Portsmouth, New Hampshire, United States
Sean Paul
Austin, Texas, United States
Standardized Patient Evaluation of Eye Dryness (SPEED)
Change dry eye symptoms evaluated by Standardized Patient Evaluation of Eye Dryness (SPEED) This questionnaire gives a score from 0 to 28. Lower score indicates better outcome. 0-4: mild, 5-7: moderate, 8+: severe Scale range: 0 (minimum; no symptoms) to 28 (maximum; most severe symptoms). Interpretation: Lower scores indicate better outcomes. Symptom severity can be categorized as: 0-4 = mild, 5-7 = moderate, 8-28 = severe.
Time frame: 6 months
Meibomian Gland Score (MGS), as Assessed by a Masked Rater
The Meibomian Gland Score (MGS) is a standardized clinical tool used to assess the functional quality of the meibomian glands, which are responsible for secreting the oily layer of the tear film. Dysfunction in these glands is a common cause of dry eye disease and evaporative dry eye. The scoring typically involves gentle expression of the meibomian glands, usually from a designated number of glands (commonly 15, e.g., 5 each from the nasal, central, and temporal parts of the lower eyelid). Each gland is evaluated based on the quality of the secretion it produces. Scoring Criteria per Gland: Each gland is scored on a 0-3 scale: 0 = No secretion 1. = Inspissated/toothpaste-like secretion 2. = Cloudy secretion 3. = Clear, healthy oil If 15 glands are assessed, the maximum total score is 45 (15 glands × 3 points per gland). A higher total MGS reflects better meibomian gland function and healthier tear film, indicating a more favorable condition.
Time frame: 6 months
Tear Break-Up Time
Tear Break-Up Time (TBUT) Changes in dry eye symptoms such as ocular fatigue or dryness will be assessed by TBUT. The measurement is reported in seconds. * Scale range: 0 seconds (minimum) to \>10 seconds (maximum normal value considered). * Interpretation: \>10 seconds = normal, 5-10 seconds = marginal, \<5 seconds = low.
Time frame: 6 months
Ocular Surface Disease Index (OSDI)
Ocular Surface Disease Index (OSDI) This 12-item questionnaire assesses dry eye symptoms and their effects. Scale range: 0 (minimum) to 100 (maximum). Interpretation: Lower scores indicate better outcomes.
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Time frame: 6 months
Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading
Change in measurements using ocular surface fluorescent staining. The NEI scale divides the corneal and conjunctival surfaces to grade fluorescein uptake. Each of 5 areas per cornea is graded 0-3. The NEI scale for grading fluorescein staining divides the corneal and conjunctival surfaces to help measure fluorescein uptake. A standardized grading system of 0 to 3 is used for each of the five areas on each cornea. Scale range: 0 (minimum; no staining) to 15 (maximum). Interpretation: Lower scores indicate better outcomes.
Time frame: 6 months
Subject's Assessment of Improvement
Subject assessment of improvement based on 0 - 4-point Likert scale. Improvement assessment will be performed independently by the subject himself on the following 0-4 points Likert scale questionnaire (Global Aesthetic Improvement Scale): 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference Scale range: 0 (no difference) to 4 (significant marked improvement).
Time frame: 6 months
Subject Assessment of Satisfaction
Subject assessment of satisfaction will be filled-out by subjects only using 5-points Likert scale: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed. Scale range: -2 (very disappointed) to +2 (very satisfied). Interpretation: Higher scores indicate better outcomes.
Time frame: 6 months
Safety Assessment
Discomfort assessment during the treatment using NSR scale. At each treatment the subject will be asked to fill assessments for the pain/discomfort during the procedure. The subject will be asked to rate the severity from 0 to 10, with 0 equaling no symptoms and 10 equaling the worst possible symptoms. A number is obtained by measuring up to the point the subject has indicated. Scale range: 0 (no pain) to 10 (worst possible pain).
Time frame: 6 weeks