Dataset Information

Performance of a Translucent Activator for LipiFlow Vectored Thermal Pulse (VTP) Treatment of Meibomian Gland Dysfunction.

ABSTRACT:

Purpose

Investigator feedback was used to assess the clinical use of the LipiFlow^® System with the new translucent Activator Clear to successfully complete LipiFlow^® treatments.

Patients and methods

This was a prospective, open-label clinical investigation. A total of 88 eyes (44 subjects) were treated using the LipiFlow^® System with the new Activator Clear. Subjects diagnosed with bilateral meibomian gland dysfunction (MGD) were enrolled in the study. Each investigator performed a complete LipiFlow^® treatment with the translucent Activator on both eyes of each subject. Investigators completed a questionnaire assessing the clinical use of the Activator Clear on a 5-point scale (1 - very difficult or strongly disagree, 3 - neutral, 5 - very easy or strongly agree).

Results

The new translucent Activator provided successful LipiFlow^® treatments in 100% of cases, with 95% confidence interval of (96%, 100%). Additionally, the investigators agreed or strongly agreed that the translucent components of the Activator Clear made it easy to access and position the activator with confidence on the subject's eye.

Conclusion

The overall investigators' impressions on usage and functionality of LipiFlow^® System with the translucent Activator were very positive. The Activator Clear enables doctors with efficient and confident positioning around patient eyelids to ensure successful LipiFlow^® treatment when used as indicated.

SUBMITTER: Hu JG

PROVIDER: S-EPMC8977218 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Performance of a Translucent Activator for LipiFlow Vectored Thermal Pulse (VTP) Treatment of Meibomian Gland Dysfunction.

Hu Jerry G JG Dang Vin T VT Chang Daniel H DH Goldberg Damien F DF McKinnon Cheryl C Makedonsky Katherine K Laron Michal M Ji Leilei L

Clinical ophthalmology (Auckland, N.Z.) 20220330

<h4>Purpose</h4>Investigator feedback was used to assess the clinical use of the LipiFlow<sup>®</sup> System with the new translucent Activator Clear to successfully complete LipiFlow<sup>®</sup> treatments.<h4>Patients and methods</h4>This was a prospective, open-label clinical investigation. A total of 88 eyes (44 subjects) were treated using the LipiFlow<sup>®</sup> System with the new Activator Clear. Subjects diagnosed with bilateral meibomian gland dysfunction (MGD) were enrolled in the st ...[more]

PMID: 35386613

Similar Datasets

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: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: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.

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.

Dataset Information

Performance of a Translucent Activator for LipiFlow Vectored Thermal Pulse (VTP) Treatment of Meibomian Gland Dysfunction.

Purpose

Patients and methods

Results

Conclusion

Publications

Performance of a Translucent Activator for LipiFlow Vectored Thermal Pulse (VTP) Treatment of Meibomian Gland Dysfunction.

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