Clinical Study of LPI on Different Sites of Iris

Study Overview
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Brief Summary
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Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an existing angle close or angle adhesion in order to reduce the risk of attack of the angle closure glaucoma. However, there are very little research on the laser site, laser wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine the optimum laser site of LPI.

Detailed Description
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Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an existing angle close or angle adhesion in order to reduce the risk of attack of the angle closure glaucoma. However, there are very little research on the laser site, laser wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine the optimum laser site of LPI. Before and 7days, 1 month, 3 months after LPI, the structure of anterior chamber, including angle anterior chamber depth(ACD), angle of anterior chamber (AA), anterior chamber angle opening distance 750(AOD750) are measured with ultrasound biomicroscopy. Before and 7days, 1 month, 3 months after LPI, the outflow resistance of aqueous humor are evaluated with C value. Before and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI, intraocular pressure are measured with Goldmann tonometry. Before and 3 months after LPI, retinal nerve layer thickness and the optic disc cup disc ratio are measure with optical coherence tomography.

Official Title
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Clinical Study of Laser Peripheral Iridoplasty on Different Sites of Iris

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Corneoscleral limbus group
* Procedure: one spot group
* Procedure: two spots group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary angle closure suspect (PACS), primary angle closure (PAC) or primary angle closure glaucoma (PACG). PACS is diagnosed in eyes with an occludable angle but no other abnormality. PAC is diagnosed in eyes with an occludable angle, normal optic discs and visual fields and any of the following: raised IOP (>19 mm Hg), PAS, pigment smearing in the superior angle, or sequelae of acute angle closure (iris whirling or glaucomatous fleck). PACG is diagnosed in eyes with an occludable angle and glaucomatous optic neuropathy. Evidence of glaucomatous optic neuropathy is defined as a cup: disc ratio (CDR) of >0.7 or >0.2 CDR asymmetry. An occludable angle is defined as one in which three quarters of the posterior pigmented trabecular meshwork is not visible on viewing with a Goldmann two mirror lens in the primary position of gaze without indentation. Exclusion Criteria: Patients with previous ocular surgery, and those with secondary angle closure, such as lens intumescence or subluxation, iris neovascularisation and a history of uveitis. Patients who have systemic contraindications to medical therapy (including renal impairment, sulfur allergy, asthma and heart failure), pre-existing corneal opacities obstructing laser access to more than one quadrant of the peripheral iris and single-eyed patients are also excluded.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: corneoscleral limbus group<br>Laser spot locates on the corneoscleral limbus. | Procedure: Corneoscleral limbus group<br>* Laser spot locates on the corneoscleral limbus<br>|
| Experimental: One spot group<br>Laser spot locates on one spot away from the corneoscleral limbus | Procedure: one spot group<br>* Laser spot locates on one spot away from the corneoscleral limbus<br>|
| Experimental: Two spots group<br>Laser spot locates on two spots away from the corneoscleral limbus | Procedure: two spots group<br>* Laser spot locates on two spots away from the corneoscleral limbus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of anterior chamber angle(AA) | Anterior chamber angle (AA) is measured with ultrasound biomicroscopy. | Baseline and 3 months after LPI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of anterior chamber angle opening distance 750(AOD750) | Anterior chamber angle opening distance 750(AOD750) is measured with ultrasound biomicroscopy. | Baseline and 3 months after LPI | 
| Change of anterior chamber depth(ACD) | Anterior chamber depth(ACD) is measured with ultrasound biomicroscopy. | Baseline and 3 months after LPI. | 
| Change of intraocular pressure (IOP) | IOP is measured with Goldmann tonometry. | Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI. | 
| Change of C value | IOP is measured with Schφtz tonometry. | Baseline and 7days, 1 month, 3 months after LPI. | 
| Change of retinal nerve layer thickness | Retinal nerve layer thickness is measured with optical coherence tomography. | Baseline and 3 months after LPI. | 
| Change of optic disc cup disc ratio | Optic disc cup disc ratio is measured with optical coherence tomography. | Baseline and 3 months after LPI. | 
| Change of mean defect | Mean defect is measured with computer perimetry. | Baseline and 3 months after LPI. | 
| Change of mean sensitivity | Mean sensitivity is measured with computer perimetry. | Baseline and 3 months after LPI. | 
| Change of scotoma | Scotoma is measured with computer perimetry. | Baseline and 3 months after LPI. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser peripheral iridoplasty, treatment