Overview

This trial is active, not recruiting.

Condition glaucoma
Treatments 532nm laser group, 561nm laser group
Sponsor First Affiliated Hospital of Fujian Medical University
Start date September 2016
End date December 2017
Trial size 30 participants
Trial identifier NCT02901730, [2016]102-2

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 wavelengths of LPI.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
LPI with 532nm laser.
532nm laser group
LPI with 532nm laser.
(Experimental)
LPI with 561nm laser.
561nm laser group
LPI with 561nm laser.

Primary Outcomes

Measure
Change of anterior chamber angle(AA)
time frame: Baseline and 3 months after LPI.

Secondary Outcomes

Measure
Change of anterior chamber angle opening distance 750(AOD750)
time frame: Baseline and 3 months after LPI.
Change of anterior chamber depth(ACD)
time frame: Baseline and 3 months after LPI.
Change of intraocular pressure (IOP)
time frame: Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI.
Change of C value
time frame: Baseline and 7days, 1 month, 3 months after LPI.
Change of retinal nerve layer thickness
time frame: Baseline and 3 months after LPI.
Change of optic disc cup disc ratio
time frame: Baseline and 3 months after LPI.
Change of mean defect
time frame: Baseline and 3 months after LPI.
Change of mean sensitivity
time frame: Baseline and 3 months after LPI.
Change of scotoma
time frame: Baseline and 3 months after LPI.

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

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.

Additional Information

Official title Clinical Study of Laser Peripheral Iridoplasty With Different Laser Wavelengths
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by First Affiliated Hospital of Fujian Medical University.