Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction
NCT Number: NCT06483750
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Eye Disease|Meibomian Gland Dysfunction|Cataract Senile|Dry Eye Syndromes
Interventions: DEVICE: Systane iLux Treatment
Sponsor: George Washington University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2024-12-01
Locations: George Washington University, Washington, District of Columbia, 20037, United States

Summary:
This prospective study will investigate the effect of pre-operative Systane iLux system administration in treated cataract induced dry eye disease.

Primary Outcome Measures: Changed in Lipid Layer Thickness (LLT) measurement from baseline visit, To assess improvement in tear film lipid layer by imaging through LipiView II. Thin lipid layer thickness (\<60 nm) indicates a tear film instability and therefore an increased evaporation rate, high osmolarity, and dry eye symptoms. In contrast, a thicker lipid layer thickness (\<120 nm) indicates a more stable tear film stability, 6 weeks
Secondary Outcome Measures: Change in standard patient evaluation of eye dryness questionnaire (SPEED) questionnaire from baseline visit, To assess the improvement of dry eye symptoms by SPEED questionnaire. 0 score is the minimum (no dry eye symptom); 64 is the maximum score (most symptomatic). Change = (Follow up visit score - Baseline score), 6 weeks|Mean change from baseline of Fluorescein Tear Break-Up Time (TBUT) from baseline visit, The shorter the TBUT, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Follow up visit value - baseline visit value). shorter the TBUT, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Follow up visit value - baseline visit value)., 6 weeks|Change in ocular surface and disease index (OSDI) score questionnaire from baseline visit, The OSDI survey provides a score from 0 to 100 with a higher score indicating a more severe symptoms of dry eye disease. A normal score fro patients without dry eye would be 12 or below, while a score of 13 to 22 indicates mild disease, 23 to 32 indicates moderate disease, and patients with a score above 33 are characterized as having severe eye disease. Change = (Follow up visit score - Baseline visit score), 6 weeks|Change from baseline in Meibomian Gland Score (MGS), Meibomian glands on the eyelids assessed by the examiner using a Meibomian Gland Evaluator (MGE) and a slit lamp microscope. An MGE instrument applies a standardized force simulating the pressure of a deliberate blink allowing eye care professionals to observe meibomian gland functionality through a slit lamp. 5 glands in 3 zones (nasal, medial, temporal) evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function, 6 weeks