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Clinical Study of LPI on Different Sites of Iris

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corneoscleral limbus group
one spot group
two spots group
Sponsored by
First Affiliated Hospital of Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring laser peripheral iridoplasty, treatment

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    corneoscleral limbus group

    One spot group

    Two spots group

    Arm Description

    Laser spot locates on the corneoscleral limbus.

    Laser spot locates on one spot away from the corneoscleral limbus

    Laser spot locates on two spots away from the corneoscleral limbus

    Outcomes

    Primary Outcome Measures

    Change of anterior chamber angle(AA)
    Anterior chamber angle (AA) is measured with ultrasound biomicroscopy.

    Secondary Outcome Measures

    Change of anterior chamber angle opening distance 750(AOD750)
    Anterior chamber angle opening distance 750(AOD750) is measured with ultrasound biomicroscopy.
    Change of anterior chamber depth(ACD)
    Anterior chamber depth(ACD) is measured with ultrasound biomicroscopy.
    Change of intraocular pressure (IOP)
    IOP is measured with Goldmann tonometry.
    Change of C value
    IOP is measured with Schφtz tonometry.
    Change of retinal nerve layer thickness
    Retinal nerve layer thickness is measured with optical coherence tomography.
    Change of optic disc cup disc ratio
    Optic disc cup disc ratio is measured with optical coherence tomography.
    Change of mean defect
    Mean defect is measured with computer perimetry.
    Change of mean sensitivity
    Mean sensitivity is measured with computer perimetry.
    Change of scotoma
    Scotoma is measured with computer perimetry.

    Full Information

    First Posted
    August 10, 2016
    Last Updated
    September 11, 2016
    Sponsor
    First Affiliated Hospital of Fujian Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02870504
    Brief Title
    Clinical Study of LPI on Different Sites of Iris
    Official Title
    Clinical Study of Laser Peripheral Iridoplasty on Different Sites of Iris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital of Fujian Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma
    Keywords
    laser peripheral iridoplasty, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    corneoscleral limbus group
    Arm Type
    Experimental
    Arm Description
    Laser spot locates on the corneoscleral limbus.
    Arm Title
    One spot group
    Arm Type
    Experimental
    Arm Description
    Laser spot locates on one spot away from the corneoscleral limbus
    Arm Title
    Two spots group
    Arm Type
    Experimental
    Arm Description
    Laser spot locates on two spots away from the corneoscleral limbus
    Intervention Type
    Procedure
    Intervention Name(s)
    Corneoscleral limbus group
    Intervention Description
    Laser spot locates on the corneoscleral limbus
    Intervention Type
    Procedure
    Intervention Name(s)
    one spot group
    Intervention Description
    Laser spot locates on one spot away from the corneoscleral limbus
    Intervention Type
    Procedure
    Intervention Name(s)
    two spots group
    Intervention Description
    Laser spot locates on two spots away from the corneoscleral limbus
    Primary Outcome Measure Information:
    Title
    Change of anterior chamber angle(AA)
    Description
    Anterior chamber angle (AA) is measured with ultrasound biomicroscopy.
    Time Frame
    Baseline and 3 months after LPI
    Secondary Outcome Measure Information:
    Title
    Change of anterior chamber angle opening distance 750(AOD750)
    Description
    Anterior chamber angle opening distance 750(AOD750) is measured with ultrasound biomicroscopy.
    Time Frame
    Baseline and 3 months after LPI
    Title
    Change of anterior chamber depth(ACD)
    Description
    Anterior chamber depth(ACD) is measured with ultrasound biomicroscopy.
    Time Frame
    Baseline and 3 months after LPI.
    Title
    Change of intraocular pressure (IOP)
    Description
    IOP is measured with Goldmann tonometry.
    Time Frame
    Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI.
    Title
    Change of C value
    Description
    IOP is measured with Schφtz tonometry.
    Time Frame
    Baseline and 7days, 1 month, 3 months after LPI.
    Title
    Change of retinal nerve layer thickness
    Description
    Retinal nerve layer thickness is measured with optical coherence tomography.
    Time Frame
    Baseline and 3 months after LPI.
    Title
    Change of optic disc cup disc ratio
    Description
    Optic disc cup disc ratio is measured with optical coherence tomography.
    Time Frame
    Baseline and 3 months after LPI.
    Title
    Change of mean defect
    Description
    Mean defect is measured with computer perimetry.
    Time Frame
    Baseline and 3 months after LPI.
    Title
    Change of mean sensitivity
    Description
    Mean sensitivity is measured with computer perimetry.
    Time Frame
    Baseline and 3 months after LPI.
    Title
    Change of scotoma
    Description
    Scotoma is measured with computer perimetry.
    Time Frame
    Baseline and 3 months after LPI.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maosong Xie, doctor
    Organizational Affiliation
    Department of ophthalmology, First Affilited Hospital of Fujian Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26886121
    Citation
    Lai J, Choy BN, Shum JW. Management of Primary Angle-Closure Glaucoma. Asia Pac J Ophthalmol (Phila). 2016 Jan-Feb;5(1):59-62. doi: 10.1097/APO.0000000000000180.
    Results Reference
    background
    PubMed Identifier
    26707418
    Citation
    Narayanaswamy A, Baskaran M, Perera SA, Nongpiur ME, Htoon HM, Tun TA, Wong TT, Goh D, Su DH, Chew PT, Ho CL, Aung T. Argon Laser Peripheral Iridoplasty for Primary Angle-Closure Glaucoma: A Randomized Controlled Trial. Ophthalmology. 2016 Mar;123(3):514-21. doi: 10.1016/j.ophtha.2015.11.002. Epub 2015 Dec 23.
    Results Reference
    background
    PubMed Identifier
    26518079
    Citation
    Marchini G, Chemello F, Berzaghi D, Zampieri A. New findings in the diagnosis and treatment of primary angle-closure glaucoma. Prog Brain Res. 2015;221:191-212. doi: 10.1016/bs.pbr.2015.05.001. Epub 2015 Jun 30.
    Results Reference
    background
    PubMed Identifier
    26294102
    Citation
    Sng CC, Aquino MC, Liao J, Zheng C, Ang M, Chew PT. Anterior segment morphology after acute primary angle closure treatment: a randomised study comparing iridoplasty and medical therapy. Br J Ophthalmol. 2016 Apr;100(4):542-8. doi: 10.1136/bjophthalmol-2015-307087. Epub 2015 Aug 20.
    Results Reference
    background
    PubMed Identifier
    26119516
    Citation
    Wright C, Tawfik MA, Waisbourd M, Katz LJ. Primary angle-closure glaucoma: an update. Acta Ophthalmol. 2016 May;94(3):217-25. doi: 10.1111/aos.12784. Epub 2015 Jun 27.
    Results Reference
    background
    PubMed Identifier
    23286475
    Citation
    Fu J, Qing GP, Wang NL, Wang HZ. Efficacy of laser peripheral iridoplasty and iridotomy on medically refractory patients with acute primary angle closure: a three year outcome. Chin Med J (Engl). 2013 Jan;126(1):41-5.
    Results Reference
    background
    PubMed Identifier
    21860572
    Citation
    Lee JR, Choi JY, Kim YD, Choi J. Laser peripheral iridotomy with iridoplasty in primary angle closure suspect: anterior chamber analysis by pentacam. Korean J Ophthalmol. 2011 Aug;25(4):252-6. doi: 10.3341/kjo.2011.25.4.252. Epub 2011 Jul 22.
    Results Reference
    background
    PubMed Identifier
    20577108
    Citation
    Mochizuki H, Takenaka J, Sugimoto Y, Takamatsu M, Kiuchi Y. Comparison of the prevalence of plateau iris configurations between angle-closure glaucoma and open-angle glaucoma using ultrasound biomicroscopy. J Glaucoma. 2011 Jun-Jul;20(5):315-8. doi: 10.1097/IJG.0b013e3181e3d2da.
    Results Reference
    background

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    Clinical Study of LPI on Different Sites of Iris

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