Effect of Systane iLux on Dry Eye Disease Before Cataract Surgery
The Efficacy of the Systane iLux System on Preoperative Cataract Patients on Dry Eye Disease Due to Meibomian Gland Dysfunction
NA · George Washington University · NCT06483750
This study is testing if using Systane iLux for two weeks before cataract surgery can help people with dry eye disease feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | George Washington University (other) |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT06483750 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate the impact of pre-operative Systane iLux treatment on patients scheduled for senile cataract surgery who also suffer from dry eye disease due to meibomian gland dysfunction. Participants will be divided into two groups: one receiving the Systane iLux treatment two weeks prior to surgery and a control group receiving no treatment. Various metrics related to dry eye disease, including tear break up time and patient-reported symptoms, will be assessed before and after the surgery to determine any significant changes resulting from the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for senile cataract surgery and have dry eye disease due to meibomian gland dysfunction.
Not a fit: Patients with active ocular infections, significant ocular surface abnormalities, or recent ocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve dry eye symptoms in patients undergoing cataract surgery.
How similar studies have performed: While similar approaches have been explored, this specific application of Systane iLux in the context of cataract surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington, District of Columbia
- George Washington University — Washington, District of Columbia, United States (RECRUITING)
Study contacts
- Principal investigator: Keith Wroblewski, MD — George Washington MFA
- Study coordinator: Arnold Leigh, BS
- Email: arnold.leigh@gwu.edu
- Phone: 7039670226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dry Eye Disease, Meibomian Gland Dysfunction, Cataract Senile, Dry Eye Syndromes