Photobiomodulation of the Ocular Surface and Eyelids With Different Wavelengths: REd vs BluE Light (REBEL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 1 Month After Final Treatment Session
研究概览
简要总结
The use of photobiomodulation or low-level light therapy (LLLT) in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration. There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms, tear film stability and tear volume. Despite the observed clinical benefits, limited research has been done to compare photobiomodulation utilising different wavelengths, as most research on dry eye disease has focused on red wavelengths. It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues, although research into these differential impacts at the ocular surface and external eye has been limited. Hence, the aim of this exploratory clinical trial is to compare the impact of using LLLT incorporating red versus blue wavelengths on eyelid haemodynamics and microbiome, as well as conventional ocular surface measures of patients with dry eye disease and blepharitis (inflammation of the eyelids).
Participants with dry eye disease, oil gland disruption and blepharitis will receive 3 treatments with these LLLT, each separted by 1 week apart, and followed up to 1 month after the final treatment session. Participants will be randomised to either of 3 groups: Red light only group, Red + Blue light group, or a sham treatment group.
详细描述
This study will be a randomized, double-masked, exploratory clinical study to assess the potential difference in impact between the two wavelengths used for LLLT. The whole study involves a total of 4 visits (consisting of 3 treatment visits, and 1 follow-up visit). 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)
- •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 1 to grade 4 of either eyelid [Pult and Reide-Pult, 2013]) will also justify a diagnosis of Meibomian gland dysfunction.
- •Individuals will also need to have ocular demodicosis, diagnosed by clinical observation on slit lamp biomicroscope based on signs including collarettes around the base of lashes, visible Demodex tails, or excessive pouting of lash follicles in those with good lid hygiene where Demodex was confirmed by secondary means such as visible Demodex tails.
- •Age ≥ 18 years, male or female
- •Able to provide written consent in English
- •Able to attend a total of 4 visits: 3 treatment visits and followed up for 1 month after final treatment
排除标准
- •Pregnancy
- •Ocular light-based therapies including intense pulsed light (IPL) or LLLT treatment within the past 1 month or during study period in addition to those provided in the study
- •Contact lens wear in the past 2 weeks or during study period
- •Other active ocular surface diseases or history of ocular surgery or corneal infections the past 6 months
结局指标
主要结局
Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 1 Month After Final Treatment Session
时间窗: Baseline and 1 month after final treatment session
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 Tear Meniscus Height to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Blood Flow to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Bacterial Colony to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Demodex Presence to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Meibum Quality to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Visual Acuity to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Blink Rate to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Limbal Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Saponification Grading to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in MMP-9 Tear Concentration to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Meibum Expressibility to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Bulbar Conjunctival Staining to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in Meibography Meiboscore to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)
- Change from Baseline in LTA Tear Concentration to the Final Follow-up 1 Month After Final Treatment Session(Baseline up to 1 month after final treatment session)