Diamond Bur Microblepharoexfoliation Combined With Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye: A Short-term Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Meibomian gland secretions (MGS)
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy and safety of microblepharoeexfoliation (MBE), intense pulse light (IPL) and meibomian gland expression (MGX) combination in patients with meibomian gland dysfunction (MGD).
The main question it aims to answer are:
- Does MBE-IPL-MGX treatment improve dry eye symptoms?
- Does MBE-IPL-MGX treatment improve dry eye signs?
Participants were assigned to receive either three sessions of MBE-IPL-MGX treatment and home-based therapy (treatment group) or home-based therapy alone (control group).
The investigators will compare both groups to see if MBE-IPL-MGX treatment is superior to home-based therapy.
详细描述
MBE is a novel in-office treatment that works by exfoliating the eyelid margins to remove the accumulated biofilm debris, epithelial keratinization and capped meibomian glands, resulting in better meibum outflow . Different studies have shown that MBE improves DED symptoms [1,2], demodex blepharitis [1-4] and meibomian gland function [2,3,5] In addition, meta-analyses recommend combining IPL with meibomian gland expression (MGX) compared to IPL or MGX alone [6-8]. However, the investigators have not found any studies evaluating the benefits of MBE combined with IPL and MGX.
Consequently, the purpose of the current study is to evaluate whether MBE combined with IPL and MGX leads to an improvement of symptoms and signs in patients with DED due to MGD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •DED diagnosis according to DEWS II meeting one of the following conditions: (2.1) ocular surface disease index (OSDI) score ≥ 13; (2.2) NIBUT < 10 seconds; and (2.3) ocular surface staining with > 5 or 9 corneal or conjunctival stains, respectively.
- •MGD diagnosis according to the international workshop on MGD meeting two of the following conditions: (3.1) irregularity of the eyelid margin or mucocutaneous junction; (3.2) vascularity of the eyelid margin; (3.3) plugged or capped Meibomian gland orifices; (3.4) Meibomian gland atrophy; or (3.5) decreased meibum quality and quantity
排除标准
- •Skin pathologies that prevent IPL treatment
- •All corneal disorders that affect diagnostic tests, such as: (2.1) active corneal infections; and (2.2) corneal dystrophies.
- •Active ocular allergy.
- •Pregnant or lactating women..
- •Patients who did not understand or comprehend the informed consent.
研究组 & 干预措施
MBE-IPL-MGX treatment and home-based therapy.
In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
干预措施: Microblepharoexfoliation (Procedure)
MBE-IPL-MGX treatment and home-based therapy.
In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
干预措施: Intense pulse light (Procedure)
MBE-IPL-MGX treatment and home-based therapy.
In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
干预措施: Meibomian gland expression (Procedure)
MBE-IPL-MGX treatment and home-based therapy.
In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
干预措施: Home-based therapy (Drug)
Home-based therapy
In this arm, participants received home-based therapy alone.
干预措施: Home-based therapy (Drug)
结局指标
主要结局
Meibomian gland secretions (MGS)
时间窗: Change from Baseline MGS at 2 months.
Values from 0 (Worse) to 45 (Better)
Conjunctival hyperemia
时间窗: Change from Baseline Conjunctival Hyperemia at 2 months.
Values from 0 (Better) to 100 (Worse)
Tear meniscus height (TMH)
时间窗: Change from Baseline TMH at 2 months.
Ocular surface disease index (OSDI) questionnaire.
时间窗: Change from Baseline OSDI at 2 months.
Values from 0 (Better) to 100 (Worse)
Tear meniscus area (TMA)
时间窗: Change from Baseline TMA at 2 months.
Noninvasive tear film break-up time (NIBUT).
时间窗: Change from Baseline NIBUT at 2 months.
Meibomian glands Loss area (LAMG)
时间窗: Change from Baseline LAMG at 2 months.
Values from 0 (Better) to 100 (Worse)
Ocular surface staining (OSS).
时间窗: Change from Baseline OSS at 2 months.
Values from 0 (Better) to 4 (Worse)
Lipid Layer Grade (LLG)
时间窗: Change from Baseline LLG at 2 months.
Values from 0 (Better) to 4 (Worse)
Ciliary hyperemia
时间窗: Change from Baseline Ciliary Hyperemia at 2 months.
Values from 0 (Better) to 100 (Worse)
Meibomian gland Dysfunction Grade (MGD Grade)
时间窗: Change from Baseline MGD grade at 2 months.
Values from 0 (Better) to 4 (Worse)
次要结局
未报告次要终点
研究者
Antonio Ballesteros Sánchez
Principal Investigator
University of Seville