Dataset Information

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

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.

SUBMITTER: Wesley G

PROVIDER: S-EPMC9639411 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

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

Wesley Gina G Bickle Katherine K Downing Johnathon J Fisher Bret B Greene Brennan B Heinrich Colton C Kading David D Kannarr Shane S Miller Jason J Modi Satish S Ludwick David D Tauber Joseph J Yeh Thao N TN Srinivasan Sruthi S

Clinical ophthalmology (Auckland, N.Z.) 20221103

<h4>Purpose</h4>This study aimed to demonstrate the effectiveness of Systane iLux, a thermal pulsation device, in patients with MGD, over 12 months post-single treatment.<h4>Methods</h4>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 E ...[more]

PMID: 36353670

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Project description:PurposeTo evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye.MethodsThe prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group).ResultsAt 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378).ConclusionA single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes.

Project description:SignificanceMeibomian gland dysfunction (MGD) is among the most common causes of dry eye disease worldwide. Few studies have compared treatment options, and the basis for an evidentiary approach to MGD management is lacking. We have conducted a non-randomized trial evaluating the additive benefit of a recently developed therapy.PurposeTo compare the efficacy of thermal pulsation therapy alone or combined with the dexamethasone intracanalicular insert (Dextenza) on the signs and symptoms of MGD.MethodsThis was a prospective, patient-masked, sham-controlled, non-randomized trial. All subjects underwent thermal pulsation therapy using the LipiFlow system. The dexamethasone intracanalicular insert was placed in the inferior canaliculus of the more symptomatic eye (DEX group), while sham punctal dilation of the fellow eye was performed to preserve patient masking (SHAM group). Key outcomes were improvement in meibum expressibility at 1, 4, and 12 weeks and patient treatment preference at week 12.ResultsNineteen subjects underwent thermal pulsation therapy and received the DEX insert. Meibomian gland expressibility scores improved significantly in both groups at 1, 4, and 12 weeks, with significantly greater improvement in DEX eyes than SHAM eyes at 12 weeks (P=0.027). Improvement from baseline in TBUT was significant at all time points in DEX eyes and only at week 4 in SHAM eyes, with significantly greater improvement in DEX eyes over SHAM eyes at week 12 (P=0.028). Mean best-corrected visual acuity and intraocular pressure remained unchanged from baseline throughout follow-up in both groups, and no adverse events were noted. Combined therapy with DEX was preferred by 61% of subjects.ConclusionThis study demonstrated a significant benefit of combining thermal pulsation therapy with the dexamethasone intracanalicular insert on signs of MGD including TBUT and meibomian gland expressibility score. Consequently, a majority of patients preferred combination therapy to thermal pulsation therapy alone.

Project description:IntroductionPatients implanted with a range-of-vision intraocular lens (IOL) (multifocal or extended depth of focus, EDOF) may be more susceptible to visual disturbances from poor tear film quality, and prophylactic treatment of meibomian gland dysfunction (MGD) has been recommended. The purpose was to evaluate whether vectored thermal pulsation (LipiFlow™) treatment prior to cataract surgery with a range-of-vision IOL safely improves postoperative outcomes.MethodsThis is a prospective, randomized, open-label, crossover, multicenter study of patients with mild-to-moderate MGD and cataract. The test group underwent LipiFlow treatment prior to cataract surgery and implantation of an EDOF IOL, while the control group did not. Both groups were evaluated 3 months postoperatively, after which the control group received LipiFlow treatment (crossover). The control group was re-evaluated 4 months postoperatively.ResultsA total of 121 subjects were randomized, with 117 eyes in the test group and 115 eyes in the control group. At 3 months after surgery, the test group had a significantly greater improvement from baseline in total meibomian gland score compared with the control group (P = 0.046). At 1 month after surgery, the test group had a significant decrease in corneal (P = 0.04) and conjunctival (P = 0.002) staining compared to the control group. At 3 months after surgery, the test group had significantly lower incidence of being bothered by halos compared with the control group (P = 0.019). The control group had a significantly lower incidence of being bothered by multiple or double vision compared with the test group (P = 0.016). After crossover, patients had significant improvement in vision (P = 0.03) and total meibomian gland score (P < 0.0001). No safety concerns or relevant safety findings were uncovered.ConclusionPresurgical LipiFlow treatment of patients implanted with range-of-vision IOLs improved meibomian gland function and postoperative ocular surface health. This supports guidelines recommending proactive diagnosis and management of MGD in patients with cataracts to improve patient experience.Trial registrationThe study was registered on www.Clinicaltrialsgov (NCT03708367).

Project description:Purpose:To evaluate the effect of a single vectored thermal pulsation (VTP) treatment in contact lens wearers with meibomian gland dysfunction (MGD) and dry eye symptoms. Methods:The prospective, nonsignificant risk, open-label, randomized, multi-center clinical trial included 55 soft contact lens (SCL) wearers with MGD and evaporative dry eye. Subjects were randomized to the single VTP treatment group or an untreated control. The controls received a crossover VTP treatment at 3 months (crossover treatment group). Primary effectiveness measures were meibomian gland secretion (MGS) score and Standard Patient Evaluation of Eye Dryness (SPEED) that were evaluated at baseline, at 1 and 3 months post-VTP treatment, and at 1 month post-VTP treatment in the crossover treatment group. Exploratory variables included fluorescein tear break-up time (TBUT), lid wiper epitheliopathy (LWE), lid parallel conjunctival folds (LIPCOF), ocular surface staining, frequency of over-the-counter (OTC) drop use, and hours of comfortable contact lens wear. Results:At 3 months, the treatment group showed significantly greater mean change from baseline in MGS (12.4±9.1 vs 1.4±6.4, p<0.0001), SPEED (-8.4±4.7 vs -0.7±4.4, p<0.0001) and significantly greater improvement in exploratory variables (TBUT, LWE, and frequency of OTC drop use) relative to the controls. Mean comfortable contact lens wearing time increased by 4.0±3.9 hours at 1 month. This was sustained for 3 months with no change in the control group. The crossover treatment group demonstrated similar results to the treatment group at 1 month post-VTP. Conclusion:In SCL wearers with MGD, a single VTP treatment significantly improved mean meibomian gland function and significantly reduced dry eye signs and symptoms compared to an untreated control. The treatment increased mean comfortable lens wearing time by 4 hours (approximately doubling the pretreatment findings). This was sustained for up to 3 months post-treatment on average.

Dataset Information

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

Purpose

Methods

Results

Conclusion

Publications

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

Similar Datasets

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