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Clinical Study of LPI on Different Sites of Iris

Clinical Study of Laser Peripheral Iridoplasty on Different Sites of Iris

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02870504
Enrollment
60
Registered
2016-08-17
Start date
2016-07-31
Completion date
2017-12-31
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

laser peripheral iridoplasty, treatment

Brief summary

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

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.

Interventions

PROCEDURECorneoscleral limbus group

Laser spot locates on the corneoscleral limbus

PROCEDUREone spot group

Laser spot locates on one spot away from the corneoscleral limbus

PROCEDUREtwo spots group

Laser spot locates on two spots away from the corneoscleral limbus

Sponsors

First Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of anterior chamber angle(AA)Baseline and 3 months after LPIAnterior chamber angle (AA) is measured with ultrasound biomicroscopy.

Secondary

MeasureTime frameDescription
Change of anterior chamber depth(ACD)Baseline and 3 months after LPI.Anterior chamber depth(ACD) is measured with ultrasound biomicroscopy.
Change of intraocular pressure (IOP)Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI.IOP is measured with Goldmann tonometry.
Change of C valueBaseline and 7days, 1 month, 3 months after LPI.IOP is measured with Schφtz tonometry.
Change of retinal nerve layer thicknessBaseline and 3 months after LPI.Retinal nerve layer thickness is measured with optical coherence tomography.
Change of anterior chamber angle opening distance 750(AOD750)Baseline and 3 months after LPIAnterior chamber angle opening distance 750(AOD750) is measured with ultrasound biomicroscopy.
Change of mean defectBaseline and 3 months after LPI.Mean defect is measured with computer perimetry.
Change of mean sensitivityBaseline and 3 months after LPI.Mean sensitivity is measured with computer perimetry.
Change of scotomaBaseline and 3 months after LPI.Scotoma is measured with computer perimetry.
Change of optic disc cup disc ratioBaseline and 3 months after LPI.Optic disc cup disc ratio is measured with optical coherence tomography.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026