Clinical Study of LPI on Different Sites of Iris

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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corneoscleral limbus group

Laser spot locates on the corneoscleral limbus.

Group Type EXPERIMENTAL

Corneoscleral limbus group

Intervention Type PROCEDURE

Laser spot locates on the corneoscleral limbus

One spot group

Laser spot locates on one spot away from the corneoscleral limbus

Group Type EXPERIMENTAL

one spot group

Intervention Type PROCEDURE

Laser spot locates on one spot away from the corneoscleral limbus

Two spots group

Laser spot locates on two spots away from the corneoscleral limbus

Group Type EXPERIMENTAL

two spots group

Intervention Type PROCEDURE

Laser spot locates on two spots away from the corneoscleral limbus

Interventions

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Corneoscleral limbus group

Laser spot locates on the corneoscleral limbus

Intervention Type PROCEDURE

one spot group

Laser spot locates on one spot away from the corneoscleral limbus

Intervention Type PROCEDURE

two spots group

Laser spot locates on two spots away from the corneoscleral limbus

Intervention Type PROCEDURE

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No