Morphological Changes of Ciliary Body and Trabecular Meshwork

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05352854
• Other study ID #: Myopia-OAG SSOCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: August 2022

Study information

• Verified date: April 2022
• Source: Wenzhou Medical University
• Contact: Zhangliang Li
• Phone: 13968832833
• Email: lizhangliang0328[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Myopia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yune Zhao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, pre-intervention(local application of pilocarpine eye drops)
Primary	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	40 minutes after the intervention(local application of pilocarpine eye drops)
Primary	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	baseline, pre-intervention(local application of pilocarpine eye drops)
Primary	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	40 minutes after the intervention(local application of pilocarpine eye drops)