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Clinical Study of LPI With Different Laser Wavelengths

F

Fujian Medical University (FJMU)

Status

Unknown

Conditions

Glaucoma

Treatments

Procedure: 561nm laser group
Procedure: 532nm laser group

Study type

Interventional

Funder types

Other

Identifiers

NCT02901730
[2016]102-2

Details and patient eligibility

About

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 wavelengths of LPI.

Full 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.Conventional LPI uses wavelength 532nm laser. However, our preclinical studies have found that the laser penetration of the laser wavelength 561nm is stronger than that of the laser wavelength 532nm. It can produce a stronger contraction effect.

The purpose of this study is to determine the optimum laser wavelengths of LPI. Baseline 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. Baseline and 7days, 1 month, 3 months after LPI, the outflow resistance of aqueous humor are evaluated with C value. Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI, intraocular pressure are measured with Goldmann tonometry. Baseline and 3 months after LPI, retinal nerve layer thickness and the optic disc cup disc ratio are measure with optical coherence tomography.

Enrollment

30 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

532nm laser group
Experimental group
Description:
LPI with 532nm laser.
Treatment:
Procedure: 532nm laser group
561nm laser group
Experimental group
Description:
LPI with 561nm laser.
Treatment:
Procedure: 561nm laser group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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