Morphological Changes of Ciliary Body and Trabecular Meshwork

NCT05352854 | Unknown

• 1 other identifier: Myopia-OAG SSOCT
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma; Myopia

Keywords

ciliary body and trabecular meshwork

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (4)

Health control

EXPERIMENTAL

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

Drug: 0.5% pilocarpine eye drops

High myopia

EXPERIMENTAL

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

Drug: 0.5% pilocarpine eye drops

Primary open angle glaucoma

EXPERIMENTAL

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

Drug: 0.5% pilocarpine eye drops

HM-POAG

EXPERIMENTAL

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

Drug: 0.5% pilocarpine eye drops

Interventions

0.5% pilocarpine eye drops DRUG

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

HM-POAG; Health control; High myopia; Primary open angle glaucoma

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yune Zhao: lead

MeSH Terms

Conditions

Glaucoma; Myopia

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Refractive Errors

Study Officials

• Yune Zhao

  Ophthalmology and Optometry Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhangliang Li

CONTACT

13968832833; lizhangliang0328@126.com

Yune Zhao, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 29, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04