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

NCT ID: NCT06483750

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2024-12-01

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.

Conditions

Dry Eye Disease; Meibomian Gland Dysfunction; Cataract Senile; Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control: No Systane iLux Treatment

No Systane iLux treatment at baseline visit two weeks prior to cataract surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Systane iLux Treatment

Systane iLux administration at baseline visit two weeks prior to cataract surgery.

Group Type: EXPERIMENTAL

Systane iLux Treatment

Intervention Type: DEVICE

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.

Interventions

Systane iLux Treatment

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Wroblewski, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington MFA

Locations

George Washington University

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

Site Status: RECRUITING

Countries

United States

Central Contacts

Arnold Leigh, BS

Role: CONTACT

arnold.leigh@gwu.edu

7039670226

Keith Wroblewski, MD

Role: CONTACT

kwroblewski@mfa.gwu.edu

202-741-2800

Facility Contacts

Arnold Leigh, BS

Role: primary

arnold.leigh@gwu.edu

703-967-0226

Other Identifiers

NCR245538

Identifier Type: -

Identifier Source: org_study_id