Dataset Information

Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye.

ABSTRACT: To investigate the efficacy and safety of the MGDRx EyeBag (The Eyebag Company, Halifax, UK) eyelid warming device.Twenty-five patients with confirmed meibomian gland dysfunction (MGD)-related evaporative dry eye were enrolled into a randomised, single masked, contralateral clinical trial. Test eyes received a heated device; control eyes a non-heated device for 5?min twice a day for 2?weeks. Efficacy (ocular symptomology, non-invasive break-up time, lipid layer thickness, osmolarity, meibomian gland dropout and function) and safety (visual acuity, corneal topography, conjunctival hyperaemia and staining) measurements were taken at baseline and follow-up. Subsequent patient device usage and ocular comfort was ascertained at 6?months.Differences between test and control eyes at baseline were not statistically significant for all measurements (p>0.05). After 2?weeks, statistically significant improvements occurred in all efficacy measurements in test eyes (p<0.05). Visual acuity and corneal topography were unaffected (p>0.05). All patients maintained higher ocular comfort after 6?months (p<0.05), although the benefit was greater in those who continued usage 1-8 times a month (p<0.001).The MGDRx EyeBag is a safe and effective device for the treatment of MGD-related evaporative dry eye. Subjective benefit lasts at least 6?months, aided by occasional retreatment.NCT01870180.

SUBMITTER: Bilkhu PS

PROVIDER: S-EPMC4251196 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye.

Bilkhu Paramdeep Singh PS Naroo Shehzad Anjam SA Wolffsohn James Stuart JS

The British journal of ophthalmology 20140704 12

<h4>Background/aims</h4>To investigate the efficacy and safety of the MGDRx EyeBag (The Eyebag Company, Halifax, UK) eyelid warming device.<h4>Methods</h4>Twenty-five patients with confirmed meibomian gland dysfunction (MGD)-related evaporative dry eye were enrolled into a randomised, single masked, contralateral clinical trial. Test eyes received a heated device; control eyes a non-heated device for 5 min twice a day for 2 weeks. Efficacy (ocular symptomology, non-invasive break-up time, lipid ...[more]

PMID: 24997178

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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:BackgroundDry eye disease (DED), Meibomian gland dysfunction (MGD), and Sjögren's syndrome dry eye disease (SS-DED) are eye dryness conditions that show significant overlap in various symptoms of ocular discomfort. The aim of this study was to qualitatively explore the patient experience and evaluate content validity of the newly developed Dry Eye Disease Questionnaire (DED-Q).MethodsSemi-structured interviews were conducted with 61 US adults who reported experiencing ocular symptoms due to their physician-confirmed primary diagnosis of DED (n = 21), MGD (n = 20), or SS-DED (n = 20). The open-ended concept-elicitation phase was followed by cognitive debriefing (CD) of the DED-Q to evaluate participants' understanding and relevance of the instructions, items, response options, and recall periods. Interviews were also conducted with eight specialist healthcare professionals to assess clinical relevance of the concepts included. Verbatim interview transcripts were analyzed using thematic analysis in ATLAS.ti v8 software.ResultsA total of 29 symptoms and 14 impacts on quality of life were reported across participant interviews. Primary ocular symptoms reported included eye dryness (n = 61/61; 100%), eye irritation (n = 55/61; 90%), eye itch (n = 54/61; 89%), burning sensation (n = 52/61; 85%), and foreign body sensation (n = 51/61; 84%). The most impacted aspects of daily life were using digital screens (n = 46/61; 75%), driving (n = 45/61; 74%), working (n = 39/61; 64%), and reading (n = 37/61; 61%). CD findings showed most participants had good understanding of DED-Q items and confirmed most concepts were relevant to the lived experience of their condition. Aside from few minor changes to the items and examples to facilitate more accurate interpretation, the proposed instruction wording was modified for various symptom and impact modules to encourage participants to focus only on dry eye vision problems.ConclusionsThis research identified multiple prevalent symptoms and impacts of DED, MGD, and SS-DED, most of which were similar across the conditions. The DED-Q was confirmed to be a content-valid PRO measure suitable for use in clinical studies to assess the patient experience of DED, MGD, and SS-DED. Future work will focus on evaluating the psychometric properties of the DED-Q for use as an efficacy endpoint in clinical trials.

Project description:IntroductionPrimary Sjögren's syndrome (pSS) is a systemic autoimmune disorder that primarily affects the exocrine glands such as the lacrimal and the salivary glands. Dry eye disease (DED) is one of the most prevalent manifestations of pSS and is usually classified into aqueous-deficient dry eye and evaporative dry eye. Sjögren's syndrome dry eye (SSDE) is generally described as aqueous-deficient dry eye. However, as the leading pathophysiological mechanism of evaporative dry eye, meibomian gland dysfunction (MGD) also has influence on SSDE, which has been shown in recent studies. We speculate that SSDE is more than just an aqueous-deficient dry eye. While no related systematic review and meta-analysis has been published, the present study is designed to derive a better understanding of the association between MGD and SSDE.Methods and analysisThe Preferred Reporting items for Systematic Reviews and Meta-Analysis for Protocols 2015 statement was used to prepare this protocol. PubMed, Embase, Web of Science, Cochrane Database, China National Knowledge Infrastructure and Wan Fang Database will be searched from their inception to 31 October 2021, with restrictions to publications in English or Chinese. Two reviewers will independently carry out data extraction and quality assessment. The diagnosis of pSS will meet the standard diagnostic criteria, such as American College of Rheumatology/European League against Rheumatism Classification Criteria (ACR/EULAR) or American-European Consensus Group Classification criteria (AECG), and the definition of MGD and DED will differ between studies. The quality of included studies will be judged using the Newcastle-Ottawa Quality Scale. We will carry out this meta-analysis using RevMan V.5.4.1. The incidence of MGD in patients with SSDE will be indicated as OR with 95% CI.Ethics and disseminationEthical approval is not required as this meta-analysis is performed based on published studies and does not involve human participants. The results will be published in a peer-reviewed journal.Prospero registration numberCRD42021226017.

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

Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye.

Publications

Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye.

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