Morphological Changes of Ciliary Body and Trabecular Meshwork

Sponsor
Yune Zhao (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05352854
Collaborator
(none)
120
4
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.5% pilocarpine eye drops
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Health control

emmetropia/low myopia (equivalent spherical lens > -3.00d, astigmatism ≤ 1.5d), best corrected visual acuity ≥1.0

Drug: 0.5% pilocarpine eye drops
Subjects will be given 0.5% pilocarpine eye drops every five minutes for three times and wait for 40 minutes

Experimental: High myopia

Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm

Drug: 0.5% pilocarpine eye drops
Subjects will be given 0.5% pilocarpine eye drops every five minutes for three times and wait for 40 minutes

Experimental: Primary open angle glaucoma

emmetropia/low myopia (equivalent spherical lens > -3.00d, astigmatism ≤ 1.5d), diagnosed as POAG

Drug: 0.5% pilocarpine eye drops
Subjects will be given 0.5% pilocarpine eye drops every five minutes for three times and wait for 40 minutes

Experimental: HM-POAG

Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm,diagnosed as POAG

Drug: 0.5% pilocarpine eye drops
Subjects will be given 0.5% pilocarpine eye drops every five minutes for three times and wait for 40 minutes

Outcome Measures

Primary Outcome Measures

  1. Morphology of ciliary body [baseline, pre-intervention(local application of pilocarpine eye drops)]

    measurement of Morphology of ciliary body using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software

  2. Morphology of ciliary body [40 minutes after the intervention(local application of pilocarpine eye drops)]

    measurement of Morphology of ciliary body using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software

  3. Morphology of trabecular meshwork [baseline, pre-intervention(local application of pilocarpine eye drops)]

    measurement of Morphology of trabecular meshwork using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software

  4. Morphology of trabecular meshwork [40 minutes after the intervention(local application of pilocarpine eye drops)]

    measurement of Morphology of trabecular meshwork using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yune Zhao

Investigators

  • Principal Investigator: Yune Zhao, Ophthalmology and Optometry Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05352854
Other Study ID Numbers:
  • Myopia-OAG SSOCT
First Posted:
Apr 29, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
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
Keywords provided by Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022