Back to resultsClinical Study of LPI With Different Laser Wavelengths
Primary Purpose
Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
532nm laser group
561nm laser group
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring laser peripheral iridoplasty, treatment
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
532nm laser group
561nm laser group
Arm Description
LPI with 532nm laser.
LPI with 561nm laser.
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
NCT ID
NCT02901730
First Posted
September 11, 2016
Last Updated
September 11, 2016
Sponsor
First Affiliated Hospital of Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02901730
Brief Title
Clinical Study of LPI With Different Laser Wavelengths
Official Title
Clinical Study of Laser Peripheral Iridoplasty With Different Laser Wavelengths
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 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 wavelengths 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.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.
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
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
532nm laser group
Arm Type
Experimental
Arm Description
LPI with 532nm laser.
Arm Title
561nm laser group
Arm Type
Experimental
Arm Description
LPI with 561nm laser.
Intervention Type
Procedure
Intervention Name(s)
532nm laser group
Intervention Description
LPI with 532nm laser.
Intervention Type
Procedure
Intervention Name(s)
561nm laser group
Intervention Description
LPI with 561nm laser.
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
result
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
result
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
result
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
result
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
result
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
result
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
result
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
result
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Clinical Study of LPI With Different Laser Wavelengths
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