Managing Dry Eye in Patients Using Glaucoma Drops

He Eye Hospital60 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye

Interventions

IPLDEVICE

Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

He Eye Hospital

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

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.

Time frame: Day-0 (baseline), 2-week, 4-weeks

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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