Comparative Effects of USB-Powered Warm Compress and Self-Heating Eye Mask in the Management of Meibomian Gland Dysfunction
USB-Powered vs. Self-Heating Warm Compresses for Meibomian Gland Dysfunction: A Prospective Randomized Crossover Trial
Why was this study done?
People with Meibomian Gland Dysfunction (MGD) often have dry, irritated eyes because the tiny oil glands in their eyelids do not work properly. Applying gentle heat to the eyelids is a common way to improve the flow of oil and relieve symptoms.
This study wanted to find out whether a USB-powered warm compress or a self-heating disposable eye mask works better and feels more comfortable for patients with MGD.
Who took part?
Adults diagnosed with Meibomian Gland Dysfunction were invited to participate. Each person tried both treatments, one after the other, with a short break between them (this is called a crossover design).
What did participants do?
In one treatment phase, participants used a USB-powered warm compress for about 10 minutes per day over two weeks.
In the other phase, they used a self-heating disposable eye mask for the same amount of time.
The order of treatments was randomized to avoid bias.
Before and after each treatment, eye tests and comfort questionnaires were completed.
What did the study measure?
The main goal was to see if the treatments improved:
Tear film stability (how long the tears stay on the eye surface)
Meibomian gland function (how well the glands release oil)
Eye comfort and dryness symptoms
What were the results?
Both the USB-powered warm compress and the self-heating eye mask helped improve tear stability and comfort.
However, the USB-powered device provided slightly better results in improving gland function and patient satisfaction.
No serious side effects or discomfort were reported.
What do these results mean?
Regular eyelid warming is an effective way to manage MGD and dry eye symptoms. Both devices are safe and easy to use, but a USB-powered warm compress may offer stronger and more consistent heat for better results.
Patients and eye-care professionals can choose the device that best fits daily routines, comfort, and lifestyle.
Who conducted the study?
The study was carried out by optometrists and vision scientists specializing in ocular surface disease and dry eye therapy.
It followed ethical approval and was reviewed by an institutional research board before beginning.
Why is this study important?
MGD is one of the most common causes of dry eye disease worldwide. Understanding which home-based treatment works best helps patients, families, and clinicians make informed choices about safe and effective care options.
연구 개요
상세 설명
Meibomian gland dysfunction (MGD) is a leading cause of evaporative dry eye, characterized by obstruction and altered secretion of the meibomian glands that results in tear film instability and ocular discomfort. Thermal therapy is considered a cornerstone in the management of MGD, as controlled eyelid warming can enhance lipid flow, reduce stagnation, and restore tear film quality. However, the effectiveness and convenience of commercially available warming devices may vary depending on their design and heat delivery mechanisms.
This randomized, prospective, crossover clinical trial was designed to compare the efficacy and user experience of two commonly used warming modalities: a USB-powered eyelid warming device and a disposable self-heating eye mask. Each participant received both interventions in separate treatment phases, with a washout period in between, to minimize inter-subject variability. The order of intervention was randomized, ensuring balanced exposure across participants.
The study primarily aimed to assess changes in tear film stability and meibomian gland function following each treatment. Additional measures included ocular surface comfort, tear meniscus height, and patient preference. Standardized clinical assessments were conducted before and after each intervention phase, and validated questionnaires were used to capture subjective symptoms and usability feedback. Safety and tolerability were monitored throughout all sessions.
This investigation sought to generate comparative data on the short-term outcomes of two practical home-based treatment methods for MGD. The crossover design provided the advantage of within-subject comparison, enhancing the precision of treatment effect estimates. The findings are expected to inform clinicians about device selection for eyelid warming therapy and contribute to patient-centered recommendations in dry eye and ocular surface management.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Central Region
-
Riyadh, Central Region, 사우디 아라비아, RIAYDH 113
- King Saud University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18-40 years diagnosed with Meibomian Gland Dysfunction (MGD).
Baseline NITBUT < 10 seconds.
Willing to discontinue other lid therapies during the study period.
Exclusion Criteria:
- Active ocular infection or inflammation.
Recent ocular surgery (<3 months).
Use of contact lenses during the study period.
Systemic diseases affecting tear film (e.g., Sjögren's syndrome).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: USB-Powered Warm Compress
Will use A USB-Powered Warm Compress constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks
|
A constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks.
다른 이름들:
A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks.
|
|
실험적: Disposable eye mask
The group will use A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks
|
A constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks.
다른 이름들:
A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Tear Meniscus Height
기간: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
|
To assess the tear film.
The test was performed before and after each treatment phase to determine the improvement in tear film integrity following the application of each eyelid warming device.
|
Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
|
|
Ocular Surface Disease Index
기간: Baseline
|
he OSDI, which was created by the Outcomes Research Group at Allergan Inc in order to quickly assess the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision.[5] This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life.[6] The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.[7] The OSDI assesses quality of life measures, which aligns the questionnaire with Federal Food and Drug Administration's emphasis on utilizing patient-reported |
Baseline
|
|
tear break-up time
기간: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
|
Non-Invasive Tear Break-Up Time (NITBUT) to assess the stability and uniformity of the tear film.
The test was performed before and after each treatment phase to determine the improvement in tear film integrity following the application of each eyelid warming device.
|
Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
|
|
Standard Patient Evaluation of Eye Dryness
기간: Baseline at Day 1 and post intervention at Day 5.
|
The SPEED questionnaire was designed by Korb and Blackie in order to quickly track the progression of dry eye symptoms over time.[9]
This questionnaire gives a score from 0 to 28 that is the result of 8 items that assess frequency and severity of symptoms.
The symptoms assessed include dryness, grittiness, scratchiness, irritation, burning, watering, soreness, and eye fatigue.
The questionnaire further assesses whether these symptoms were not problematic, tolerable, uncomfortable, bothersome, or intolerable.[10]
The questionnaire also monitored diurnal and symptoms changes over 3 months.[11]
Validity of the questionnaire was determined by seeing how well it was able to segregate patients based on their symptoms, relative to the OSDI questionnaire (gold standard).
The resulting sensitivity and specificity were 0.90 and 0.80 respectively.[11]
|
Baseline at Day 1 and post intervention at Day 5.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ali M ALSAQR, PHD, King Saud University
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB No. E-25-9589
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .