Morphological Changes of Ciliary Body and Trabecular Meshwork
Primary Purpose
Glaucoma, Myopia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
0.5% pilocarpine eye drops
Sponsored by
About this trial
This is an interventional other trial for Glaucoma focused on measuring ciliary body and trabecular meshwork
Eligibility Criteria
Inclusion Criteria:
- Emmetropia/low myopia,high myopia, primary open-angle glaucoma without high myopia, and high myopia with primary open-angle glaucoma
- have a good gaze to complete the test required inspection;
Exclusion Criteria:
- hypersensitivity to pilocarpine
- History of eye surgery, including cataract surgery, anti-glaucoma surgery, corneal surgery, retinal surgery, and eye trauma
- history of systemic diseases that may affect the eyes (such as diabetes, hypertension, etc.)
- intraocular chronic inflammatory diseases (uveitis, etc.), retinal diseases (retinal detachment, diabetic retinopathy, retinitis pigmentosa, etc.)
- Corneal scars and severe cataracts affect OCT imaging
- Eye diseases (angle-closure glaucoma, abnormal anterior segment development, neovascularization, etc.) that can affect trabecular meshwork and Schlemm canal structure.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Health control
High myopia
Primary open angle glaucoma
HM-POAG
Arm Description
emmetropia/low myopia (equivalent spherical lens > -3.00d, astigmatism ≤ 1.5d), best corrected visual acuity ≥1.0
Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm
emmetropia/low myopia (equivalent spherical lens > -3.00d, astigmatism ≤ 1.5d), diagnosed as POAG
Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm,diagnosed as POAG
Outcomes
Primary Outcome Measures
Morphology of ciliary body
measurement of Morphology of ciliary body using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software
Morphology of ciliary body
measurement of Morphology of ciliary body using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software
Morphology of trabecular meshwork
measurement of Morphology of trabecular meshwork using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software
Morphology of trabecular meshwork
measurement of Morphology of trabecular meshwork using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05352854
Brief Title
Morphological Changes of Ciliary Body and Trabecular Meshwork
Official Title
In Vivo Morphological Changes of Ciliary Body and Trabecular Meshwork in High Myopia Eyes With Open-angle Glaucoma in Their Accommodation Induced by Pilocarpine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yune Zhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Glaucoma is the leading cause of irreversible blindness worldwide. Although the pathogenesis remains unclear, pathologic increase in intraocular pressure (IOP) due to blocked aqueous outflow through the trabecular-Schlemm canal is known to be an important risk factor, and reduction of IOP is the only clinically validated way to retard the progression of OAG. Ciliary muscle plays a central role in the trabecular meshwork-Schlemm canal outflow pathway. Clinical evidence suggests that ciliary muscle contraction stimulated by cholinergic receptor agonist and retraction of ciliary body position after cataract surgery can dilate the lumen of Schlemm canal and reduce IOP. Currently, Ultrasound biomicroscopy (UBM) can obtain two-dimensional images of the anterior segment using high-frequency Ultrasound transducers in medical imaging studies of the ciliary body - trabecular meshwork -Schlemm canal complex. UBM has better tissue penetration than Optical coherence tomography (OCT) and can image the ciliary body better, but it has a lower resolution (30um to 50um) and is poor at imaging tiny tissues such as trabecular meshwork and Schlemm canal. The latest swept-source OCT (SS-OCT) has faster image capture rate (1000000 A scans/SEC), stronger penetration and higher resolution (8um axial resolution and 20um transverse resolution). The structure and morphology of ciliary body-trabecular meshwork-Schlemm canal complex can be clearly photographed. The investigators intend to use CASIA2 to image the ciliary body-trabecular meshwork-Schlemm canal complex before and after administration of pilocarpine in healthy individuals and patients with glaucoma to assess the effect of pilocarpine on the anatomy of the ciliary body-trabecular meshwork-Schlemm canal complex.
Detailed Description
Glaucoma is the leading cause of irreversible blindness worldwide. Although the pathogenesis remains unclear, pathologic increase in intraocular pressure (IOP) due to blocked aqueous outflow through the trabecular-Schlemm canal is known to be an important risk factor, and reduction of IOP is the only clinically validated way to retard the progression of OAG. Ciliary muscle plays a central role in the trabecular meshwork-Schlemm canal outflow pathway. When the ciliary muscle contraction, the elastic fiber network will pull trabecular meshwork away from Schlemm canal direction, trabecular meshwork and adjacent tissue gap increases, increasing aqueous outflow. Clinical evidence suggests that ciliary muscle contraction stimulated by cholinergic receptor agonist and retraction of ciliary body position after cataract surgery can dilate the lumen of Schlemm canal and reduce IOP. Currently, Ultrasound biomicroscopy (UBM) can obtain two-dimensional images of the anterior segment using high-frequency Ultrasound transducers in medical imaging studies of the ciliary body - trabecular meshwork -Schlemm canal complex. UBM has better tissue penetration than Optical coherence tomography (OCT) and can image the ciliary body better, but it has a lower resolution (30um to 50um) and is poor at imaging tiny tissues such as trabecular meshwork and Schlemm canal. The latest swept-source OCT (SS-OCT) has faster image capture rate (1000000 A scans/SEC), stronger penetration and higher resolution (8um axial resolution and 20um transverse resolution). The structure and morphology of ciliary body-trabecular meshwork-Schlemm canal complex can be clearly photographed. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can accurately image the ciliary body-trabecular meshwork-Schlemm canal complex. The investigators intend to use CASIA2 to image the ciliary body-trabecular meshwork-Schlemm canal complex before and after administration of pilocarpine in healthy individuals and patients with glaucoma to assess the effect of pilocarpine on the anatomy of the ciliary body-trabecular meshwork-Schlemm canal complex.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Myopia
Keywords
ciliary body and trabecular meshwork
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Health control
Arm Type
Experimental
Arm Description
emmetropia/low myopia (equivalent spherical lens > -3.00d, astigmatism ≤ 1.5d), best corrected visual acuity ≥1.0
Arm Title
High myopia
Arm Type
Experimental
Arm Description
Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm
Arm Title
Primary open angle glaucoma
Arm Type
Experimental
Arm Description
emmetropia/low myopia (equivalent spherical lens > -3.00d, astigmatism ≤ 1.5d), diagnosed as POAG
Arm Title
HM-POAG
Arm Type
Experimental
Arm Description
Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm,diagnosed as POAG
Intervention Type
Drug
Intervention Name(s)
0.5% pilocarpine eye drops
Intervention Description
Subjects will be given 0.5% pilocarpine eye drops every five minutes for three times and wait for 40 minutes
Primary Outcome Measure Information:
Title
Morphology of ciliary body
Description
measurement of Morphology of ciliary body using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software
Time Frame
baseline, pre-intervention(local application of pilocarpine eye drops)
Title
Morphology of ciliary body
Description
measurement of Morphology of ciliary body using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software
Time Frame
40 minutes after the intervention(local application of pilocarpine eye drops)
Title
Morphology of trabecular meshwork
Description
measurement of Morphology of trabecular meshwork using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software
Time Frame
baseline, pre-intervention(local application of pilocarpine eye drops)
Title
Morphology of trabecular meshwork
Description
measurement of Morphology of trabecular meshwork using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software
Time Frame
40 minutes after the intervention(local application of pilocarpine eye drops)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Emmetropia/low myopia,high myopia, primary open-angle glaucoma without high myopia, and high myopia with primary open-angle glaucoma
have a good gaze to complete the test required inspection;
Exclusion Criteria:
hypersensitivity to pilocarpine
History of eye surgery, including cataract surgery, anti-glaucoma surgery, corneal surgery, retinal surgery, and eye trauma
history of systemic diseases that may affect the eyes (such as diabetes, hypertension, etc.)
intraocular chronic inflammatory diseases (uveitis, etc.), retinal diseases (retinal detachment, diabetic retinopathy, retinitis pigmentosa, etc.)
Corneal scars and severe cataracts affect OCT imaging
Eye diseases (angle-closure glaucoma, abnormal anterior segment development, neovascularization, etc.) that can affect trabecular meshwork and Schlemm canal structure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhangliang Li
Phone
13968832833
Email
lizhangliang0328@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yune Zhao, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yune Zhao
Organizational Affiliation
Ophthalmology and Optometry Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Morphological Changes of Ciliary Body and Trabecular Meshwork
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