Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy

Conditions
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Glaucoma, Closed-Angle, Glaucoma, Narrow-Angle, Glaucoma, Angle-Closure

Intervention / Treatment
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* Drug: Dexamethasone Disodium Phosphate 0.1%
* Drug: Nepafenac 0.1%
* Drug: Hydroxyethylcellulose 0.19%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of primary narrow/closed angle by gonioscopy Able to give consent Ability to attend follow-up visits Exclusion Criteria: Corneal disease preventing sufficient evaluation of the angle Secondary closed angle (e.g. uveitis related) Pregnant women Previous eye surgery other than laser refractive correction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSAIDs-Placebo<br>Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye | Drug: Nepafenac 0.1%<br>* four drops a day for four days after LPI treatment<br>* Other names: Nevanac;Drug: Hydroxyethylcellulose 0.19%<br>* four drops a day for four days after LPI treatment<br>* Other names: Lyteers ophthalmic solution;|
| Active Comparator: Placebo-NSAIDs<br>Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye | Drug: Nepafenac 0.1%<br>* four drops a day for four days after LPI treatment<br>* Other names: Nevanac;Drug: Hydroxyethylcellulose 0.19%<br>* four drops a day for four days after LPI treatment<br>* Other names: Lyteers ophthalmic solution;|
| Active Comparator: Steroid-Placebo<br>Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye | Drug: Dexamethasone Disodium Phosphate 0.1%<br>* four drops a day for four days after LPI treatment<br>* Other names: Sterodex;Drug: Hydroxyethylcellulose 0.19%<br>* four drops a day for four days after LPI treatment<br>* Other names: Lyteers ophthalmic solution;|
| Active Comparator: Placebo-Steroids<br>Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye | Drug: Dexamethasone Disodium Phosphate 0.1%<br>* four drops a day for four days after LPI treatment<br>* Other names: Sterodex;Drug: Hydroxyethylcellulose 0.19%<br>* four drops a day for four days after LPI treatment<br>* Other names: Lyteers ophthalmic solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser peripheral iridotomy, topical anti-inflammatory drops