NCT06265454

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 0.05% or 0.01% and placebo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

February 11, 2024

Last Update Submit

February 16, 2024

Conditions

Myopia ProgressionAxial Length, EyeSclera Thickness

Keywords

myopialow doseatropine eye dropsmypoic childrenmyopia progressionLAMP

Outcome Measures

Primary Outcomes (1)

  • change in the average Choroidal Thickness over follow up period.

    Follow up of choroidal thickness during treatment period

    from enrollment till end of eye drops trial over 3 months and after stopping the drops for 3 months

Study Arms (3)

myopic children atropine 0.05%

ACTIVE COMPARATOR

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.

Drug: low dose atropine eye drops

myopic children atropine 0.01%

ACTIVE COMPARATOR

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.

Drug: low dose atropine eye drops

myopic children placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

low dose atropine eye dropsDRUG

Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies.

myopic children atropine 0.01%myopic children atropine 0.05%
PlaceboDRUG

placebo

myopic children placebo

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age ranges from 6 to 12.
  • Spherical equivalent ≥ -1.0 D.

You may not qualify if:

  • Astigmatism ≥ 3.0 D.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Abbasia, 11517, Egypt

Location

Related Publications (16)

  • 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.

    PMID: 27713535BACKGROUND

  • 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.

    PMID: 36782174BACKGROUND

  • 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.

    PMID: 33320168BACKGROUND

  • 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.

    PMID: 30514630BACKGROUND

  • 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.

    PMID: 34926529BACKGROUND

  • 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.

    PMID: 35184254BACKGROUND

  • 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.

    PMID: 26686963BACKGROUND

  • 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.

    PMID: 29109514BACKGROUND

  • 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.

    PMID: 35918918BACKGROUND

  • 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.

    PMID: 24907431BACKGROUND

  • 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.

    PMID: 20801115BACKGROUND

  • 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.

    PMID: 26769180BACKGROUND

  • 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.

    PMID: 33390025BACKGROUND

  • 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.

    PMID: 36836139BACKGROUND

  • 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.

    PMID: 25447120BACKGROUND

  • 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.

    PMID: 21446921BACKGROUND

Related Links

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Aya Mahmoud, Master's

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aya MA Abd El wahab, masters

CONTACT

1009192526ayamah711@gmail.com

Amany AF Al shazly, MD

CONTACT

100 185 9928Amany_elshazly@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 11, 2024

First Posted

February 20, 2024

Study Start

September 1, 2024

Primary Completion

December 30, 2025

Study Completion

March 30, 2026

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)