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

George Washington University (GW)

Status

Enrolling

Conditions

Cataract Senile

Meibomian Gland Dysfunction

Dry Eye Syndromes

Dry Eye Disease

Treatments

Device: Systane iLux Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06483750

NCR245538

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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