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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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPL group | Experimental | IPL group will use 2 sessions of IPL therapy, 15 days apart for the management of drug-induced dry eye in glaucoma patients. |
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| Control group | No Intervention | The control group received no treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPL | Device | Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Eric Pazo | He Eye Hospital, Shenyang, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| He Eye Hospital | Shenyang | Liaoning | 110001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39055379 | Derived | Zhang H, Qi Y, Chen J, Qin G, Xu L, He W, Yu S, Che H, Pazo EE. Management of Glaucoma-Related Dry Eye Disease with Intense Pulsed Light: A Randomized Control Study. Clin Ophthalmol. 2024 Jul 15;18:2061-2072. doi: 10.2147/OPTH.S471426. eCollection 2024. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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Prospective, comparative pilot study
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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.
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 |