Morphological Changes of Ciliary Body and Trabecular Meshwork

NCT ID: NCT05352854

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Glaucoma Myopia

Keywords

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ciliary body and trabecular meshwork

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Health control

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

Group Type EXPERIMENTAL

0.5% pilocarpine eye drops

Intervention Type DRUG

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

High myopia

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

Group Type EXPERIMENTAL

0.5% pilocarpine eye drops

Intervention Type DRUG

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

Primary open angle glaucoma

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

Group Type EXPERIMENTAL

0.5% pilocarpine eye drops

Intervention Type DRUG

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

HM-POAG

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

Group Type EXPERIMENTAL

0.5% pilocarpine eye drops

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yune Zhao

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yune Zhao

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology and Optometry Hospital

Central Contacts

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Zhangliang Li

Role: CONTACT

Phone: 13968832833

Email: [email protected]

Yune Zhao, MD

Role: CONTACT

Other Identifiers

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Myopia-OAG SSOCT

Identifier Type: -

Identifier Source: org_study_id