Managing Dry Eye in Patients Using Glaucoma Drops

Study Overview
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Brief Summary
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A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

Detailed Description
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To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;

Official Title
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Managing Dry Eye in Patients Using Glaucoma Drops

Conditions
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Dry Eye

Intervention / Treatment
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* Device: IPL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Able and willing to comply with the treatment/follow-up schedule Bilateral signs and symptoms of dry eye disease Exclusion Criteria: Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease Patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study. Previous ocular surgery or trauma 1-month history of blepharal and periorbital skin disease or allergies Severe dry eyes with corneal epithelial defect Limbic keratitis Pterygium Corneal neovascularization Breastfeeding Rheumatic immune systemic diseases Herpes zoster infection Pregnant women Allergic to fluorescein Contact lens wearers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, comparative pilot study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPL group<br>IPL group will use 2 sessions of IPL therapy, 15 days apart for the management of drug-induced dry eye in glaucoma patients. | Device: IPL<br>* Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.<br>* Other names: Intense pulsed light;|
| No Intervention: Control group<br>The control group received no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive tear break-up time | Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded. | Day-0 (baseline), 2-week, 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival hyperemia (RS score) | Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0. | Day-0 (baseline), 2-week, 4-weeks | 
| Quality of meibum grade | Meibum quality will be assessed under a slit-lamp: Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum). | Day-0 (baseline), 2-week, 4-weeks | 
| Expressibility of meibum grade | Meibum expressibility will be assessed under a slit-lamp: Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible; 1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands. | Day-0 (baseline), 2-week, 4-weeks | 
| Conjunctivocorneal epithelial staining grade | Conjunctivocorneal epithelial staining will be assessed under a slit-lamp: Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac. The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (severe). | Day-0 (baseline), 1-week, 2-weeks | 
| Tear Film Lipid Layer | Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). | Day-0 (baseline), 2-week, 4-weeks | 
| OSDI Score | Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will beused to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points | Day-0 (baseline), 2-week, 4-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, IPL, Diquafosol, Drug-induced Dry Eye