---
title: Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction
nct_id: NCT06483750
overall_status: COMPLETED
phase: NA
sponsor: George Washington University
study_type: INTERVENTIONAL
primary_condition: Dry Eye Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06483750.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06483750"
ct_last_update_post_date: 2026-02-05
last_seen_at: "2026-05-12T06:51:44.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06483750](https://clinicaltrials.gov/study/NCT06483750)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** George Washington University
- **Conditions:** Dry Eye Disease, Meibomian Gland Dysfunction, Cataract Senile, Dry Eye Syndromes
- **Start Date:** 2024-06-03
- **Completion Date:** 2025-02-01
- **CT.gov Last Update:** 2026-02-05

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Control: No Systane iLux Treatment** (NO_INTERVENTION) — No Systane iLux treatment at baseline visit two weeks prior to cataract surgery.
- **Systane iLux Treatment** (EXPERIMENTAL) — Systane iLux administration at baseline visit two weeks prior to cataract surgery.

## Interventions

- **Systane iLux Treatment** (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.

## Primary Outcomes

- **Changed in Lipid Layer Thickness (LLT) measurement from baseline visit** _(time frame: 6 weeks)_ — To assess improvement in tear film lipid layer by imaging through LipiView II. Thin lipid layer thickness (\<60 nm) indicates a tear film instability and therefore an increased evaporation rate, high osmolarity, and dry eye symptoms. In contrast, a thicker lipid layer thickness (\<120 nm) indicates a more stable tear film stability

## Secondary Outcomes

- **Change in standard patient evaluation of eye dryness questionnaire (SPEED) questionnaire from baseline visit** _(time frame: 6 weeks)_
- **Mean change from baseline of Fluorescein Tear Break-Up Time (TBUT) from baseline visit** _(time frame: 6 weeks)_
- **Change in ocular surface and disease index (OSDI) score questionnaire from baseline visit** _(time frame: 6 weeks)_
- **Change from baseline in Meibomian Gland Score (MGS)** _(time frame: 6 weeks)_

## Locations (1)

- George Washington University, Washington D.C., District of Columbia, United States

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.george washington university|washington d.c.|district of columbia|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06483750*  
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