Evidence map›Paper›PMID 36353670›Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2022

Systane iLux Thermal Pulsation System in the Treatment of Meibomian Gland Dysfunction: A Post-Hoc Analysis of a 12-Month, Randomized, Multicenter Study.

Gina Wesley, Katherine Bickle, Johnathon Downing, Bret Fisher, Brennan Greene, Colton Heinrich, David Kading, Shane Kannarr, Jason Miller, Satish Modi and 4 more

Registry-linked trialOpen access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03956225 (Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03956225 nacompletednot on this map

Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study

TypeinterventionalSponsorAlcon ResearchRan2019 to 2020Enrolled299ConditionsMeibomian Gland Dysfunction, Evaporative Dry Eye DiseaseArmsSystane iLux® Dry Eye System, LipiFlow® Thermal Pulsation System
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Efficacy of eyelid warming therapies in contact lens-related dry eye and comfortable wearing time: a systematic review with meta-analysis.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2026
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. The ILuxInternational journal of ophthalmology · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 1 country.

Gina WesleyComplete Eye Care of Medina, Hamel, MN, USA.
Katherine BickleProCare Vision Center, Granville, OH, USA.
Johnathon DowningEast West Eye Institute, Los Angeles, CA, USA.
Bret FisherEye Center of N Florida, Panama City, FL, USA.
Brennan GreeneThe Eye Care Institute, Louisville, KY, USA.
Colton HeinrichClarke EyeCare Center, Wichita Falls, TX, USA.
David KadingSpecialty Eyecare Group, Bellevue, WA, USA.
Shane KannarrKannarr Eye Care LLC, Pittsburg, KS, USA.
Jason MillerInsight Research Clinic, Powell, OH, USA.
Satish ModiAlterman, Modi & Wolter, Poughkeepsie, NY, USA.ORCID 0000-0002-8054-9006
David LudwickLudwick Eye Center, Chambersburg, PA, USA.
Joseph TauberTauber Eye Center, Kansas City, MO, USA.ORCID 0000-0001-5365-8795
Thao N YehAlcon Vision, LLC, Fort Worth, TX, USA.ORCID 0000-0001-6008-5278
Sruthi SrinivasanAlcon Research, LLC, Johns Creek, GA, USA.
Alcon (United States) · USAltera (United States) · USComplete Eye Care of Medina · USEye Care Associates · USEye Center of North Florida · USSouthern California Eye Institute · USTauber Eye Center · USThe Eye Care Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This study aimed to demonstrate the effectiveness of Systane iLux, a thermal pulsation device, in patients with MGD, over 12 months post-single treatment. Methods: This is a post-hoc analysis of a previous prospective, assessor-masked, parallel-group, multicenter study (NCT03956225) that compared the effectiveness and safety of iLux with LipiFlow in subjects with MGD. The original study included subjects with meibomian gland score (MGS) ≤12 in lower eyelids, Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score >16, and non-invasive tear break-up time (NITBUT) <10 seconds. Subjects were randomized (1:1) to receive a single bilateral treatment of iLux or LipiFlow. In this post-hoc analysis, mean changes in MGS, NITBUT (first break-up; seconds), IDEEL-SB module score, and corneal staining, from baseline to 12 months were analyzed post-single treatment with iLux. Results: Data from 119 patients (n=238 eyes) treated with iLux were analyzed. The mean±SD age of the subjects was 58.4±13.4 years, with majority being female (79.0%). MGS (mean±SD) for both eyes improved significantly from baseline to 12 months (OD [baseline: 6.9±3.69; month 12: 22.8±11.31; change: 15.9±11.57, p<0.0001]; OS [baseline: 6.4±3.66; month 12: 23.0±11.33; change: 16.7±11.40, p<0.0001]). Similarly, significant improvements were observed in NITBUT (OD [baseline: 5.2±1.97; month 12: 7.0±3.68; change: 1.9±3.69, p<0.0001]; OS [baseline: 5.6±1.96; month 12: 7.9±4.58; change: 2.3±4.59, p<0.0001]) and IDEEL-SB score (p<0.0001). Corneal staining reduced significantly from baseline to 12 months (OD [baseline: 2.1±2.96; month 12: 0.7±1.56; change: -1.4±2.65, p<0.0001]; OS [baseline: 2.1±2.94; month 12: 0.7±1.44; change: -1.4±2.75, p<0.0001]). Improvements in MGS, NITBUT, IDEEL-SB module score, and corneal staining were seen as early as week 2, and at months 1, 3, 6, and 9 (all p<0.001). Conclusion: A single treatment with iLux significantly improved clinical parameters of MGS, NITBUT, and corneal staining, and patient-reported symptom assessment with IDEEL-SB in patients with MGD over 12 months.

Indexed as

corneal stainingmeibomian gland dysfunctionmeibomian gland scoretear break-up time

Identifiers

PMID36353670
PMCPMC9639411
OpenAlexW4307977488

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.