Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction

George Washington University30 enrolled

Overview

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

Eligible patients to be recruited will have scheduled upcoming senile cataract surgery. Enrolled patients in the active arm (n=25) will receive pre-operative Systane iLux treatment two weeks prior to surgery at the baseline visit. Patients in the control arm will receive no Systane iLux treatment at the baseline visit two weeks prior to cataract surgery. Patients will be assessed on baseline metrics for dry eye disease stemming and meibomian gland dysfunction (MGD) at the baseline visit two weeks prior to cataract surgery. These metrics include tear break up time (TBUT), standard patient evaluation of eye dryness questionnaire (SPEED), ocular surface and surface disease index (OSDI) surveys, and lipid layer thickness (LLT). At the follow up visit four weeks after cataract surgery, these same metrics will be assessed again for any significant changes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye Disease Meibomian Gland Dysfunction Cataract Senile Dry Eye Syndromes

Interventions

Systane iLux TreatmentDEVICE

The Systane iLux is an approved thermal pulsation device to treat dry eye disease. The application of heat and compression to both eyelids melts meibum in the obstructed glands to restore the secretion and production of meibum to the eye. The Systane iLux will only be administered to the eye to undergo cataract surgery.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age greater than 18 at the time of informed consent * Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions * Upcoming scheduled senile cataract surgery Exclusion Criteria: * Eyelid abnormalities * Patients with active ocular infection, active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months * Ocular surgery within the last 6 months * Occlusion therapy with lacrimal or punctum plugs within the last 3 months * Patients with an ocular surface abnormality that may compromise corneal integrity * Patients with ocular injury or trauma, chemical burns, or limbal stem cell deficiency (within prior 3 months) * Patients with cicatricial lid margin disease * patients with lid surface abnormalities that affect lid function in either eye; patients with aphakia * Patients with permanent makeup or tattoos on their eyelids. * Previous application/administration of Systane iLux or LipiFlow treatment

Locations (1)

George Washington University

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

Lipid layer thickness (LLT) was measured using LipiView II and reported in nanometers (nm). Higher values indicate a thicker lipid layer and improved tear film stability. Assessments were performed at both time points in the eye undergoing cataract surgery (one eye per participant). Change was calculated as the value at 4 weeks post-operatively minus the value at baseline. Negative values indicate a decrease from baseline.

Time frame: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

Secondary Outcomes

Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

The SPEED questionnaire assesses dry eye symptom severity on a scale from 0 to 64, with higher scores indicating more severe symptoms. Assessments were performed at both time points. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Negative values indicate improvement in symptoms.

Time frame: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

The OSDI questionnaire assesses dry eye symptom severity on a scale from 0 to 100, with higher scores indicating more severe symptoms. Assessments were performed at both time points. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Negative values indicate improvement in symptoms.

Time frame: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery

Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

Meibomian gland morphology was assessed using infrared meibography with the LipiView II system. Gland dropout was graded on a standardized ordinal scale from 0 to 3 (0 = no gland loss; 3 = \>66% gland loss), with higher scores indicating greater structural gland loss. Assessments were performed at both time points in the eye undergoing cataract surgery (one eye per participant). Analyses were conducted at the participant level. Change was calculated as the score at 4 weeks post-operatively minus the score at baseline. Positive values indicate worsening gland loss.

Data from ClinicalTrials.gov

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