Low Dose Atropine Eye Drops in Myopic Egyptian Children (LAMP)

February 16, 2024 updated by: aya mahmoud, Ain Shams University

Effect of Low Concentration Atropine Eye Drops on Choroidal Thickness, Central Corneal Thickness, Anterior Scleral Thickness and Axial Length in Myopic Children

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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).

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 11517
        • Ain Shams University
        • Contact:
        • Principal Investigator:
          • Marwa M Abd al Karim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: low dose atropine eye drops
Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies.
Active Comparator: 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.
Drug: low dose atropine eye drops
Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies.
Placebo Comparator: 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.
Drug: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the average Choroidal Thickness over follow up period.
Time Frame: from enrollment till end of eye drops trial over 3 months and after stopping the drops for 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Aya Mahmoud, Master's, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDAED IN MC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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