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Clinical Study of LPI With Different Laser Wavelengths

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ClinicalTrials.gov Identifier: NCT02901730
Recruitment Status : Unknown
Verified September 2016 by Maosong Xie, First Affiliated Hospital of Fujian Medical University.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Maosong Xie, First Affiliated Hospital of Fujian Medical University

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 wavelengths of LPI.

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: 532nm laser group Procedure: 561nm laser group Not Applicable

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.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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study of Laser Peripheral Iridoplasty With Different Laser Wavelengths
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: 532nm laser group
LPI with 532nm laser.
Procedure: 532nm laser group
LPI with 532nm laser.

Experimental: 561nm laser group
LPI with 561nm laser.
Procedure: 561nm laser group
LPI with 561nm laser.




Primary Outcome Measures :
  1. Change of anterior chamber angle(AA) [ Time Frame: Baseline and 3 months after LPI. ]
    Anterior chamber angle (AA) is measured with ultrasound biomicroscopy.


Secondary Outcome Measures :
  1. Change of anterior chamber angle opening distance 750(AOD750) [ Time Frame: Baseline and 3 months after LPI. ]
    Anterior chamber angle opening distance 750(AOD750) is measured with ultrasound biomicroscopy.

  2. Change of anterior chamber depth(ACD) [ Time Frame: Baseline and 3 months after LPI. ]
    Anterior chamber depth(ACD) is measured with ultrasound biomicroscopy.

  3. Change of intraocular pressure (IOP) [ Time Frame: Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI. ]
    IOP is measured with Goldmann tonometry.

  4. Change of C value [ Time Frame: Baseline and 7days, 1 month, 3 months after LPI. ]
    IOP is measured with Schφtz tonometry.

  5. Change of retinal nerve layer thickness [ Time Frame: Baseline and 3 months after LPI. ]
    Retinal nerve layer thickness is measured with optical coherence tomography.

  6. Change of optic disc cup disc ratio [ Time Frame: Baseline and 3 months after LPI. ]
    Optic disc cup disc ratio is measured with optical coherence tomography.

  7. Change of mean defect [ Time Frame: Baseline and 3 months after LPI. ]
    Mean defect is measured with computer perimetry.

  8. Change of mean sensitivity [ Time Frame: Baseline and 3 months after LPI. ]
    Mean sensitivity is measured with computer perimetry.

  9. Change of scotoma [ Time Frame: Baseline and 3 months after LPI. ]
    Scotoma is measured with computer perimetry.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901730


Sponsors and Collaborators
First Affiliated Hospital of Fujian Medical University
Investigators
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Study Chair: Maosong Xie, doctor Department of ophthalmology, First Affilited Hospital of Fujian Medical University

Publications of Results:

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Responsible Party: Maosong Xie, Principal Investigator, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT02901730     History of Changes
Other Study ID Numbers: [2016]102-2
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maosong Xie, First Affiliated Hospital of Fujian Medical University:
laser peripheral iridoplasty
treatment
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases