Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265454
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-11
Brief Title:
Low Dose Atropine Eye Drops in Myopic Egyptian Children
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effect of Low Concentration Atropine Eye Drops on Choroidal Thickness Central Corneal Thickness Anterior Scleral Thickness and Axial Length in Myopic Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAMP
Brief Summary:
Previous Studies reported that low concentration atropine eye drops may be effective in increasing the choroidal blood flow and thickness and this slows myopia progression
purpose of the study is to compare changes in axial length anterior chamber depth choroidal thickness central corneal thickness and anterior scleral thickness among myopic children receiving atropine 005 or 001 and placebo
purpose of the study is to compare changes in axial length anterior chamber depth choroidal thickness central corneal thickness and anterior scleral thickness among myopic children receiving atropine 005 or 001 and placebo
Detailed Description:
Myopia is the most common refractive error and its prevalence rate is increasing worldwide as per WHO it is projected to increase from 22 in 2000 to 52 by 2050 It is more prevalent in developed industrial areas and affects individuals of all ages Singh et al 2022 Myopia especially the degenerative type is associated with sight-threatening complications including presenile cataract glaucoma retinal detachment choroidal neovascularization myopic macular degeneration scleral and choroidal thinning Sanchez-Cano et al 2014 and Gupta et al 2015 which makes myopia a major public health concern and finding an effective treatment to prevent myopia progression is critical Wakazono et al 2016
Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies However its actual mechanism of action is not well known Yam et al 2019
But different mechanisms were described first mechanism that atropine may induce release of dopamine causing thickening of choroid Nickla et al 2010 Second mechanismblockage of choroidal smooth muscle contraction through its anti-muscarinic action Third one increasing capillary permeability Fourth potentiating the synthesis and release of intraocular nitric oxide Yam et al2022 also it stimulates retinal expression of the transcription factor ZENK which was considered an eye growth-inhibiting signal Torii et al 2017 All these mechanisms cause thickening of the choroid and increased choroidal blood flow which has been found to play a role in the regulation of eye growth and refractive error development through inhibition of the penetration of various retinal-derived growth factors that act as mechanical barriers and slow scleral growth Nickla et al 2015 amp Guggenheim et al 2011 Also choroid can secrete growth factors that prevent scleral hypoxia Wu et al 2018
According to the Low-concentration Atropine for Myopia Progression LAMP study different atropine eye drops concentrations 005 0025 and 001 controlled myopia progression but the most effective concentration on spherical equivalent and axial length progression was 005 Yam et al 2019
Zhang et al reported in 2016 that administration of 1 atropine gel increased the choroidal thickness in young Chinese children with inhibition of eye growth
Also jiang et al in 2021 mentioned that after one week of administration of 1 atropine significant changes in spherical equivalent axial length and choroidal thickness and after cessation of the medication for 7 weeks those returned to baseline levels
In 2022 Zhou et al reported also increased sub foveal choroidal thickness and in all quadrants in myopes in contrast to increased thickness in nasal quadrant only in hyperopes and non-significant change in emmetropes
A recent study in 2023 found a dose dependent ocular biometrics changes including axial length and anterior chamber depth during low-dose atropine treatment in children with myopia Hvid-Hansen et al 2023
In Li et al study in 2021 they mentioned that younger children required higher atropine concentrations to show better responses
In 2023 Zhou et al reported thinner anterior sclera in myopes compared to emmetropes and a negative correlation between anterior scleral thickness ASTand axial length and recommended usage of AST as a tool for monitoring of myopia progression
Optical Coherence Tomography OCT is a non-invasive imaging modality it was first reported in 1991 as a diagnostic technology that provides a cross-sectional image of the retina and choroid It creates a cross-sectional map of the retina based on low-coherence interferometry Aumann et al 2019
There are two types of OCT time domain OCT and spectral domain OCT but the most widely used now is spectral domain OCT as it has scan rate between 20000 and 40000 per second which improves resolution and reduces the likelihood of missing lesions Xie et al 2021
Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies However its actual mechanism of action is not well known Yam et al 2019
But different mechanisms were described first mechanism that atropine may induce release of dopamine causing thickening of choroid Nickla et al 2010 Second mechanismblockage of choroidal smooth muscle contraction through its anti-muscarinic action Third one increasing capillary permeability Fourth potentiating the synthesis and release of intraocular nitric oxide Yam et al2022 also it stimulates retinal expression of the transcription factor ZENK which was considered an eye growth-inhibiting signal Torii et al 2017 All these mechanisms cause thickening of the choroid and increased choroidal blood flow which has been found to play a role in the regulation of eye growth and refractive error development through inhibition of the penetration of various retinal-derived growth factors that act as mechanical barriers and slow scleral growth Nickla et al 2015 amp Guggenheim et al 2011 Also choroid can secrete growth factors that prevent scleral hypoxia Wu et al 2018
According to the Low-concentration Atropine for Myopia Progression LAMP study different atropine eye drops concentrations 005 0025 and 001 controlled myopia progression but the most effective concentration on spherical equivalent and axial length progression was 005 Yam et al 2019
Zhang et al reported in 2016 that administration of 1 atropine gel increased the choroidal thickness in young Chinese children with inhibition of eye growth
Also jiang et al in 2021 mentioned that after one week of administration of 1 atropine significant changes in spherical equivalent axial length and choroidal thickness and after cessation of the medication for 7 weeks those returned to baseline levels
In 2022 Zhou et al reported also increased sub foveal choroidal thickness and in all quadrants in myopes in contrast to increased thickness in nasal quadrant only in hyperopes and non-significant change in emmetropes
A recent study in 2023 found a dose dependent ocular biometrics changes including axial length and anterior chamber depth during low-dose atropine treatment in children with myopia Hvid-Hansen et al 2023
In Li et al study in 2021 they mentioned that younger children required higher atropine concentrations to show better responses
In 2023 Zhou et al reported thinner anterior sclera in myopes compared to emmetropes and a negative correlation between anterior scleral thickness ASTand axial length and recommended usage of AST as a tool for monitoring of myopia progression
Optical Coherence Tomography OCT is a non-invasive imaging modality it was first reported in 1991 as a diagnostic technology that provides a cross-sectional image of the retina and choroid It creates a cross-sectional map of the retina based on low-coherence interferometry Aumann et al 2019
There are two types of OCT time domain OCT and spectral domain OCT but the most widely used now is spectral domain OCT as it has scan rate between 20000 and 40000 per second which improves resolution and reduces the likelihood of missing lesions Xie et al 2021
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None