Dysphotopsia Following Laser Peripheral Iridotomy

Study Overview
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Brief Summary
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To establish the correlation of the location of the Nd:YAG laser peripheral iridotomy to the post operative visual symptoms experienced by some patients. The investigators hypothesize that fully uncovered laser peripheral iridotomy will produce less significant dysphotopsia, due to avoidance of the prismatic effect produced by the tear film than those covered.

Detailed Description
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Nd:YAG LPI is a frequently performed procedure for patients who have narrow angles at risk of acute angle closure glaucoma, pupillary-block conditions, chronic angle closure, and pigment dispersion syndrome. Most complications associated with the procedure are benign and include intraocular pressure (IOP) spike, transient uveitis, hyphema, corneal or lens damage and closure of the iridotomy. Visual disturbances have been also reported but only a few papers address this specific issue. The rate of these symptoms vary between 2.7% and 4%. It is believed that these symptoms are associated with the fact that light enters through the LPI and thus creating abnormal visual symptoms. Hence it has been suggested to carefully place the LPI so that the eyelid fully covers the LPI, therefore preventing light getting through. However, reports of patients with fully covered LPIs and visual disturbances have led to hypothesize the theory that even when fully covered by the eyelid, light can access through the LPI by a base-up prism created by the tear meniscus at the lid margin. Therefore, placement of the LPI, fully covered, partially covered or totally uncovered can potentially lead to equally significant symptoms. This study will attempt to address the issue of placement of the LPI in relationship with visual symptoms.

Official Title
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Incidence of Visual Symptom Following Laser (Nd:YAG ) Peripheral Iridotomy (LPI) in Relation to Position of LPI

Conditions
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Narrow Angle Patients at Risk for Angle Closure Glaucoma

Intervention / Treatment
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* Device: Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser
* Procedure: Nd:YAG Laser Peripheral Iridotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to make the required study visit Able and willing to give consent and follow study instructions An indication to undergo laser peripheral iridotomy (narrow angles, occludeable angle at risk of acute angle closure, pupil block condition, chronic angle closure, pigment dispersion syndrome) Exclusion Criteria: Previous intraocular surgery Best corrected visual acuity worse than 20/40 Asymmetrical ptosis of more than 2mm Any active intraocular inflammation Acute attack of angle closure glaucoma

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Superior Laser Peripheral Iridotomy<br>Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser peripheral iridotomy was performed on the superior aspect of the iris in the eye being treated. This will be in the 11 to 1 o'clock position. | Device: Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser<br>* This device is used to perform the peripheral iridotomy on all patients. It is a standard of care approved device.<br>* Other names: Nd:YAG Laser;Procedure: Nd:YAG Laser Peripheral Iridotomy<br>* After application of topical anesthetic to the eye undergoing the LPI, the patient is seated at the laser machine. Abraham iridotomy lens filled with a viscous material will be used to facilitate the procedure. The thinnest area of the iris quadrant treated will be chosen. Nd:YAG Laser will be applied until iridotomy is opened satisfactory.<br>* Other names: Nd:YAG LPI;|
| Experimental: Temporal Laser Peripheral Iridotomy<br>Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser peripheral iridotomy was performed on the temporal aspect of the iris in the eye being treated. The position will be in the 2 to 4 o'clock in the left eye and 8 to 10 o'clock in the right eye. | Device: Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser<br>* This device is used to perform the peripheral iridotomy on all patients. It is a standard of care approved device.<br>* Other names: Nd:YAG Laser;Procedure: Nd:YAG Laser Peripheral Iridotomy<br>* After application of topical anesthetic to the eye undergoing the LPI, the patient is seated at the laser machine. Abraham iridotomy lens filled with a viscous material will be used to facilitate the procedure. The thinnest area of the iris quadrant treated will be chosen. Nd:YAG Laser will be applied until iridotomy is opened satisfactory.<br>* Other names: Nd:YAG LPI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Linear Dysphotopsia | The change in presence of linear dysphotopsia from baseline (prior to intervention) to 1 month after the Nd:YAG laser intervention is performed. | Baseline (Time =0),1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Visual Dysphotopsia | This includes Halo, Crescent, Ghost Images, Glare, Shadows. This records the change in the presence of these symptoms from baseline (prior to intervention) and 1 month after the Nd:YAG laser intervention. | Baseline (Time = 0), 1 month | 
| Pain Experienced | The pain experienced when the Nd:YAG procedure is performed. This is on a scale of 0-10 with 0 being no pain and 10 the most severe pain imaginable. | Procedure (Time = 0) | 
| Nd:YAG Laser Power Used | The amount of laser power used on the Nd:YAG laser to perform the intervention. | Procedure (Time = 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual Disturbances, Angle Closure Glaucoma, Laser Peripheral Iridotomy, Visual Dysphotopsia