Mechanisms of Action of Light-based Therapies in the Management of Dry Eye Disease and Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change From Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 3 Months After Final Treatment Session
研究概览
简要总结
Dry eye disease is a common condition affecting millions worldwide and costing millions in healthcare due to reduced work productivity and quality of life. The disruption of oil glands in our eyelids known as Meibomian glands, which produce the oily layer of our tears to protect it from evaporating, is one of the most common contributors of dry eye disease. Much effort has been put into developing effective treatments for this condition as new treatments are constantly being introduced to the market.
The purpose of this clinical trial is to investigate how proven light-based therapies work in treating dry eye disease and oil gland disruption. These therapies include intense-pulsed light therapy (IPL) which uses a series of light flashes on the facial skin surface, and low-level light therapy (LLLT) which uses a mask with a series of light-emitting diodes (LEDs) to warm the body cells. The main questions it aims to answer are:
- What are the short- and long-term changes associated with these treatments on the eyelids and surface of the eyes?
- Does LLLT alone work better than IPL+LLLT in treating dry eye disease and oil gland disruption?
Participants with dry eye disease and oil gland disruption will receive four treatments with these light-based therapies each separated by two to three weeks apart, and followed up two to three weeks and three months after the final treatment session. One eye of the participant will receive intense pulsed light together with low-level light therapy, while the other eye will receive only low-level light therapy with a sham intense pulsed light treatment so that the researchers can compare if clinical signs and symptoms improve in one eye more than the other.
详细描述
This study will be a randomized, double-masked, paired-eye clinical study to assess the potential difference in impact between the two treatment modalities. Each eye of the participant will be randomized to receive either IPL+LLLT or sham IPL+LLLT. The whole study involves a total of 6 visits (consisting of 4 treatment visits, and 2 follow-up visits). All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with dry eye disease symptoms (Ocular Surface Disease Index questionnaire (OSDI) score ≥ 13 or Dry Eye Questionnaire (DEQ5) score > 6) and signs (tear film instability measured with non-invasive tear break-up time < 10 s or ocular surface damage measured using special dyes placed on the front surface of the eyes that temporarily stains any aggravated or damaged cells: > 5 corneal spots, > 9 conjunctival spots or lid margin staining ≥ 2mm in length and ≥ 25% in width) (Wolffsohn et al., 2017)
- •Individuals need to also have Meibomian gland dysfunction. The diagnosis of Meibomian gland dysfunction depends on how many of 5 glands in the central lower eyelid can express oil, and the quality of the oil. A diagnosis is made if there is decreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality of oil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oil glands grade 2 to grade 4 of either eyelid [Pult and Reide-Pult, 2013]) will also justify a diagnosis of Meibomian gland dysfunction
- •Age ≥ 18 years, male or female
- •Able to provide written consent in English
- •Able to attend multiple visits (4 treatment visits) and followed up for 2 weeks and 3 months after final treatment
排除标准
- •Pregnancy
- •Contraindications to IPL treatment (Individuals with darker skin types - Fitzpatrick skin type V or VI, photosensitive epilepsy, tattoos, implants, electrical or acoustic prosthetics, semi-permanent make-up, pigmented lesions or skin cancer in the treatment area, pacemakers, use of photosensitising medication the past 3 months or during treatment period)
- •Facial or ocular IPL or LLLT treatment within the past 6 months or during study period in addition to those provided in the study
- •Use of topical medical eyedrops in the past 3 months or during study period
- •Contact lens wear in the past 2 weeks or during study period
- •Systemic conditions that can cause dry eye disease or corneal nerve loss including diabetes and Sjögren's syndrome
- •Other active ocular surface diseases or history of ocular surgery or corneal infections
- •Individuals with 1 eye
研究组 & 干预措施
Actual IPL and LLLT
IPL and LLLT will be administered using the Espansione Group Ltd Eye-light unit. Five pulses of IPL will be administered along the lower lid region of the eye after the Pult meiboscore and Fitzpatrick skin grading has been entered into the unit. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.
干预措施: Actual IPL (Device)
Actual IPL and LLLT
IPL and LLLT will be administered using the Espansione Group Ltd Eye-light unit. Five pulses of IPL will be administered along the lower lid region of the eye after the Pult meiboscore and Fitzpatrick skin grading has been entered into the unit. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.
干预措施: LLLT (Device)
Sham IPL and LLLT
Sham IPL will be administered by placing a separate empty IPL cartridge on the lower eyelid regions of the patient's other eye while a working IPL cartridge (Espansione Group Ltd Eye-light unit) simulates a light pulse pointed away from the patient's face, after entering the Pult meiboscore and Fitzpatrick skin grading into the unit. Five simulated pulses will be administered. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.
干预措施: Sham IPL (Device)
Sham IPL and LLLT
Sham IPL will be administered by placing a separate empty IPL cartridge on the lower eyelid regions of the patient's other eye while a working IPL cartridge (Espansione Group Ltd Eye-light unit) simulates a light pulse pointed away from the patient's face, after entering the Pult meiboscore and Fitzpatrick skin grading into the unit. Five simulated pulses will be administered. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.
干预措施: LLLT (Device)
结局指标
主要结局
Change From Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 3 Months After Final Treatment Session
时间窗: Baseline and 3 months after final treatment session (up to 6 months after Baseline)
Measure of the stability of tears and how fast the tears evaporate in seconds using the Oculus Keratograph 5M instrument. An average of 3 measurements is obtained.
次要结局
- Change From Baseline in Ocular Surface Disease Index Scores to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in 5-Item Dry Eye Questionnaire Scores to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Tear Meniscus Height to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Adapted Symptom Assessment Questionnaire in Dry Eye Frequency Scores to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Adapted Symptom Assessment Questionnaire in Dry Eye Severity Scores to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Partial Blinks to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Upper Lid Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Putative Dendritic Cell Density to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Lipid Layer Pattern Grading to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Visual Acuity to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Lissamine Green Bulbar Conjunctival Staining to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Lower Lid Meibography Meiboscore to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Demodex Presence to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Meibum Expressibility to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Total Blinks to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Fluorescein Corneal Staining to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Meibum Quality to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Total Central Corneal Nerve Length to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Total Inferior Whorl Nerve Length to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
- Change From Baseline in Putative Tissue-Resident Memory T-Cell Density to the Final Follow-up 3 Months After Final Treatment Session(Baseline up to 3 months after final treatment session (up to 6 months after Baseline))
研究者
Jeremy Chiang
Principal Investigator
Aston University