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The purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.
Primary closed angle glaucoma is responsible to almost half glaucoma related blindness around the world. Laser peripheral iridotomy (LPI) is a common and simple treatment used for both treatment and prevention of acute angle closure event.
Anti-inflammatory drops are commonly prescribed to patients undergoing LPI in order to prevent or reduce post-treatment discomfort. However, to date, there are no specific guidelines for post LPI anti-inflammatory treatment, nor sufficient clinical evidence regarding the efficacy of such treatment.
In the current study, the investigators aim to evaluate the effect of topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs) on post LPI symptoms and inflammation markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAIDs-Placebo | Active Comparator | Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye |
|
| Placebo-NSAIDs | Active Comparator | Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye |
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| Steroid-Placebo | Active Comparator | Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye |
|
| Placebo-Steroids | Active Comparator | Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Disodium Phosphate 0.1% | Drug | four drops a day for four days after LPI treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Using VAS pain scale | At four days post LPI treatment |
| Symptoms score | Using a modified questionnaire based on the ocular surface disease index. | At four days post LPI treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Grading of cells in the anterior chamber | Assessed by counting the number of cells in the anterior chamber and applying the SUN working group grading scheme for anterior chamber cells | At four days post LPI treatment |
| Patency of LPI by visualisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ari Leshno, MD | Contact | +972-3-5302874 | ari.leshano@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Ari Leshno, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Tel Litwinsky | Israel |
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| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
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| Nepafenac 0.1% | Drug | four drops a day for four days after LPI treatment |
|
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| Hydroxyethylcellulose 0.19% | Drug | four drops a day for four days after LPI treatment |
|
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Assessed on slit-lamp examination using transilumination and visualising the site of LPI treatment for the presence (patent) or obsence (closed) of transilumination defect
| up to 30 days post LPI treatment |
| Grading of flare in anterior chamber | Assessed by counting the number of cells in the anterior chamber and applying the SUN working group grading scheme for anterior chamber flare | At four days post LPI treatment |