Clinical trial NCT06483750: Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction
Official title: The Efficacy of the Systane iLux System on Preoperative Cataract Patients on Dry Eye Disease Due to Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Meibomian Gland Dysfunction
Cataract Senile
Dry Eye Syndromes
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changed in Lipid Layer Thickness (LLT) measurement from baseline visit
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in standard patient evaluation of eye dryness questionnaire (SPEED) questionnaire from baseline visit
timeFrame: 6 weeks
measure: Mean change from baseline of Fluorescein Tear Break-Up Time (TBUT) from baseline visit
timeFrame: 6 weeks
measure: Change in ocular surface and disease index (OSDI) score questionnaire from baseline visit
timeFrame: 6 weeks
measure: Change from baseline in Meibomian Gland Score (MGS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
affiliation: George Washington MFA
name: Keith Wroblewski, MD
role: PRINCIPAL_INVESTIGATOR
References: