Dry Eye
Conditions
Keywords
Glaucoma, IPL, Diquafosol, Drug-induced Dry Eye
Brief summary
A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.
Detailed description
To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;
Interventions
DEVICEIPL
Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.
Sponsors
He Eye Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the two groups.
Intervention model description
Prospective, comparative pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive tear break-up time | Day-0 (baseline), 2-week, 4-weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of meibum grade | Day-0 (baseline), 2-week, 4-weeks | 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). |
| Expressibility of meibum grade | Day-0 (baseline), 2-week, 4-weeks | 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. |
| Conjunctival hyperemia (RS score) | Day-0 (baseline), 2-week, 4-weeks | 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. |
| Tear Film Lipid Layer | Day-0 (baseline), 2-week, 4-weeks | Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). |
| OSDI Score | Day-0 (baseline), 2-week, 4-weeks | 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 |
| Conjunctivocorneal epithelial staining grade | Day-0 (baseline), 1-week, 2-weeks | 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). |
Countries
China
Outcome results
None listed