An interventional study of 0.5% pilocarpine eye drops in Glaucoma and Myopia, sponsored by Yune Zhao. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Yune Zhao · Not applicable, Interventional, and Other
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.
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.
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's planned enrollment of 120 is above the median of 65 across 1,296 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Yune Zhao is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Exclusion Criteria:
emmetropia/low myopia (equivalent spherical lens \> -3.00d, astigmatism ≤ 1.5d), best corrected visual acuity ≥1.0
Drug: 0.5% pilocarpine eye drops
Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm
Drug: 0.5% pilocarpine eye drops
emmetropia/low myopia (equivalent spherical lens \> -3.00d, astigmatism ≤ 1.5d), diagnosed as POAG
Drug: 0.5% pilocarpine eye drops
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 40 minutes after the intervention(local application of pilocarpine eye drops)
No study locations are listed for this record.
Start is estimated for May 2022; primary completion for Jun 2022, 1 month later.
Of 272 non-industry interventional studies with no phase under Glaucoma, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 55. This study's planned 1 month is below that.
Counting every sponsor, half of 355 studies reached it within 29 months; a quarter within 15 and three quarters within 55.
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pilocarpine
Yune Zhao