Low Dose Atropine Eye Drops in Myopic Egyptian Children
NCT ID: NCT06265454
Last Updated: 2024-02-20
Study Results
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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NOT_YET_RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2024-09-01
2026-03-30
Brief Summary
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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 0.05% or 0.01% and placebo.
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Detailed Description
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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 mechanism,blockage 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 al.,2022) 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 \& 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 0.05%, 0.025%, and 0.01% controlled myopia progression but the most effective concentration on spherical equivalent and axial length progression was 0.05% (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 (AST)and 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 20,000 and 40,000 per second which improves resolution and reduces the likelihood of missing lesions (Xie et al., 2021).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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myopic children atropine 0.05%
they will receive topical atropine 0.05% for 12 weeks and all investigations will be done before administration of atropine (baseline assessment), then after 1 month, 2 months, 3 months.
low dose atropine eye drops
Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies.
myopic children atropine 0.01%
they will receive topical atropine 0.01% for 12 weeks and all investigations will be done before administration of atropine (baseline assessment), then after 1 month, 2 months, 3 months.
low dose atropine eye drops
Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies.
myopic children placebo
they will receive placebo for 12 weeks and all investigations will be done before administration of placebo (baseline assessment), then after 1 month, 2 months, 3 months.
Placebo
placebo
Interventions
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low dose atropine eye drops
Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies.
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Spherical equivalent ≥ -1.0 D.
Exclusion Criteria
* History of allergy to atropine or positive skin allergy test.
* Ocular pathology otherwise myopia.
* Recent ocular surgery.
* Chronic systemic disease.
* Use of rigid contact lenses or soft contact lenses for 1 week before participating in the study
6 Years
12 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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aya mahmoud
Doctor
Principal Investigators
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Aya Mahmoud, Master's
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
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Ain shams university
Cairo, Abbasia, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Zhang Z, Zhou Y, Xie Z, Chen T, Gu Y, Lu S, Wu Z. The effect of topical atropine on the choroidal thickness of healthy children. Sci Rep. 2016 Oct 7;6:34936. doi: 10.1038/srep34936.
Zhou J, He H, Yang Q, Wang JY, You ZP, Liu LL. Comparison of anterior sclera thickness in emmetropes and myopes. BMC Ophthalmol. 2023 Feb 14;23(1):67. doi: 10.1186/s12886-023-02775-x.
Ye L, Shi Y, Yin Y, Li S, He J, Zhu J, Xu X. Effects of Atropine Treatment on Choroidal Thickness in Myopic Children. Invest Ophthalmol Vis Sci. 2020 Dec 1;61(14):15. doi: 10.1167/iovs.61.14.15.
Yam JC, Jiang Y, Tang SM, Law AKP, Chan JJ, Wong E, Ko ST, Young AL, Tham CC, Chen LJ, Pang CP. Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Ophthalmology. 2019 Jan;126(1):113-124. doi: 10.1016/j.ophtha.2018.05.029. Epub 2018 Jul 6.
Xie R, Qiu B, Chhablani J, Zhang X. Evaluation of Choroidal Thickness Using Optical Coherent Tomography: A Review. Front Med (Lausanne). 2021 Dec 3;8:783519. doi: 10.3389/fmed.2021.783519. eCollection 2021.
Wang Y, Zhu X, Xuan Y, Wang M, Zhou X, Qu X. Short-Term Effects of Atropine 0.01% on the Structure and Vasculature of the Choroid and Retina in Myopic Chinese Children. Ophthalmol Ther. 2022 Apr;11(2):833-856. doi: 10.1007/s40123-022-00476-0. Epub 2022 Feb 20.
Wakazono T, Yamashiro K, Miyake M, Nakanishi H, Oishi A, Ooto S, Tsujikawa A, Yoshimura N. Association between Eye Shape and Myopic Traction Maculopathy in High Myopia. Ophthalmology. 2016 Apr;123(4):919-21. doi: 10.1016/j.ophtha.2015.10.031. Epub 2015 Dec 11. No abstract available.
Torii H, Ohnuma K, Kurihara T, Tsubota K, Negishi K. Violet Light Transmission is Related to Myopia Progression in Adult High Myopia. Sci Rep. 2017 Nov 6;7(1):14523. doi: 10.1038/s41598-017-09388-7.
Singh H, Singh H, Latief U, Tung GK, Shahtaghi NR, Sahajpal NS, Kaur I, Jain SK. Myopia, its prevalence, current therapeutic strategy and recent developments: A Review. Indian J Ophthalmol. 2022 Aug;70(8):2788-2799. doi: 10.4103/ijo.IJO_2415_21.
Sanchez-Cano A, Orduna E, Segura F, Lopez C, Cuenca N, Abecia E, Pinilla I. Choroidal thickness and volume in healthy young white adults and the relationships between them and axial length, ammetropy and sex. Am J Ophthalmol. 2014 Sep;158(3):574-83.e1. doi: 10.1016/j.ajo.2014.05.035. Epub 2014 Jun 5.
Nickla DL, Totonelly K, Dhillon B. Dopaminergic agonists that result in ocular growth inhibition also elicit transient increases in choroidal thickness in chicks. Exp Eye Res. 2010 Nov;91(5):715-20. doi: 10.1016/j.exer.2010.08.021. Epub 2010 Aug 27.
Nickla DL, Totonelly K. Choroidal thickness predicts ocular growth in normal chicks but not in eyes with experimentally altered growth. Clin Exp Optom. 2015 Nov;98(6):564-70. doi: 10.1111/cxo.12317.
Jiang Y, Zhang Z, Wu Z, Sun S, Fu Y, Ke B. Change and Recovery of Choroid Thickness after Short-term Application of 1% Atropine Gel and Its Influencing Factors in 6-7-year-old Children. Curr Eye Res. 2021 Aug;46(8):1171-1177. doi: 10.1080/02713683.2020.1863431. Epub 2021 Jan 4.
Hvid-Hansen A, Jacobsen N, Hjortdal J, Moller F, Ozenne B, Kessel L. Low-Dose Atropine Induces Changes in Ocular Biometrics in Myopic Children: Exploring Temporal Changes by Linear Mixed Models and Contribution to Treatment Effect by Mediation Analyses. J Clin Med. 2023 Feb 17;12(4):1605. doi: 10.3390/jcm12041605.
Gupta P, Jing T, Marziliano P, Cheung CY, Baskaran M, Lamoureux EL, Wong TY, Cheung CM, Cheng CY. Distribution and determinants of choroidal thickness and volume using automated segmentation software in a population-based study. Am J Ophthalmol. 2015 Feb;159(2):293-301.e3. doi: 10.1016/j.ajo.2014.10.034. Epub 2014 Nov 5.
Guggenheim JA, Chen YP, Yip E, Hayet H, Druel V, Wang L, Erichsen JT, Tumlinson AR, Povazay B, Drexler W, Hocking PM. Pre-treatment choroidal thickness is not predictive of susceptibility to form-deprivation myopia in chickens. Ophthalmic Physiol Opt. 2011 Sep;31(5):516-28. doi: 10.1111/j.1475-1313.2011.00827.x. Epub 2011 Mar 29.
Related Links
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10.1159/000526448
Other Identifiers
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LDAED IN MC
Identifier Type: -
Identifier Source: org_study_id
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