Brief Summary

Progressive myopia can lead to severe vision loss and is associated with retinal detachment, glaucoma, and other comorbidities. Several studies have shown that off-label, low-dose atropine eye drops slow the progression of myopia. Many eye care providers are now prescribing off-label atropine eye drops for their myopic patients, with the prescribed concentrations varying amongst providers. The purpose of this study is to determine if low-dose atropine eyedrops used daily, cause adverse effects to the eyes. Patients currently using 0.01%, 0.03%, or 0.05% atropine eye drops obtained from compounding pharmacies will be assessed for associated adverse effects.

Trial Health

On Track

Trial Health Score

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

Enrollment

148

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

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

4.6 years study duration

Study Start

First participant enrolled

June 19, 2018

Completed

4.5 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed

5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2023

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed

Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

4.6 years

First QC Date

January 4, 2023

Last Update Submit

April 21, 2023

Conditions

Myopia, Progressive

Keywords

adverse eventsnearsightednessatropine

Outcome Measures

Primary Outcomes (1)

Summary of adverse events by dose level at the time of the adverse event
Summary of total adverse events and severity of adverse events, by dose level at time of the adverse event
up to 5 years

Other Outcomes (3)

Summary of Source of Atropine
up to 5 years
Summary of adverse events by starting dose
up to 5 years
Summary of demographics and medical history by atropine starting dose
up to 5 years

Interventions

Atropine SulfateDRUG

0.01%, 0.03%, or 0.05% atropine eye drops made from compounding pharmacies.

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Pediatric patients diagnosed with myopia and using either 0.01%, 0.03%, or 0.05% atropine eye drops daily, prescribed by the principal investigator.

You may qualify if:

patients diagnosed with myopia
patients must be currently using 0.01%, 0.03%, or 0.05% atropine eye drops daily
low-dose atropine eye drops must be prescribed by the principal investigator and obtained from a compounding pharmacy

You may not qualify if:

patients without myopia
patients with myopia, but not using low-dose atropine eye drops

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Scripps Healthlead

Study Sites (1)

Laura Kirkeby

San Diego, California, 92130, United States

Location

Related Publications (10)

Leo SW; Scientific Bureau of World Society of Paediatric Ophthalmology and Strabismus (WSPOS). Current approaches to myopia control. Curr Opin Ophthalmol. 2017 May;28(3):267-275. doi: 10.1097/ICU.0000000000000367.
PMID: 28212157BACKGROUND
Gong Q, Janowski M, Luo M, Wei H, Chen B, Yang G, Liu L. Efficacy and Adverse Effects of Atropine in Childhood Myopia: A Meta-analysis. JAMA Ophthalmol. 2017 Jun 1;135(6):624-630. doi: 10.1001/jamaophthalmol.2017.1091.
PMID: 28494063BACKGROUND
Pineles SL, Kraker RT, VanderVeen DK, Hutchinson AK, Galvin JA, Wilson LB, Lambert SR. Atropine for the Prevention of Myopia Progression in Children: A Report by the American Academy of Ophthalmology. Ophthalmology. 2017 Dec;124(12):1857-1866. doi: 10.1016/j.ophtha.2017.05.032. Epub 2017 Jun 29.
PMID: 28669492BACKGROUND
Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.
PMID: 21963266BACKGROUND
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
Fu A, Stapleton F, Wei L, Wang W, Zhao B, Watt K, Ji N, Lyu Y. Effect of low-dose atropine on myopia progression, pupil diameter and accommodative amplitude: low-dose atropine and myopia progression. Br J Ophthalmol. 2020 Nov;104(11):1535-1541. doi: 10.1136/bjophthalmol-2019-315440. Epub 2020 Feb 21.
PMID: 32086237BACKGROUND
Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11.
PMID: 26271839BACKGROUND
Chia A, Chua WH, Wen L, Fong A, Goon YY, Tan D. Atropine for the treatment of childhood myopia: changes after stopping atropine 0.01%, 0.1% and 0.5%. Am J Ophthalmol. 2014 Feb;157(2):451-457.e1. doi: 10.1016/j.ajo.2013.09.020. Epub 2013 Dec 4.
PMID: 24315293BACKGROUND
Yam JC, Li FF, Zhang X, Tang SM, Yip BHK, Kam KW, Ko ST, Young AL, Tham CC, Chen LJ, Pang CP. Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report. Ophthalmology. 2020 Jul;127(7):910-919. doi: 10.1016/j.ophtha.2019.12.011. Epub 2019 Dec 21.
PMID: 32019700BACKGROUND
Chua WH, Balakrishnan V, Chan YH, Tong L, Ling Y, Quah BL, Tan D. Atropine for the treatment of childhood myopia. Ophthalmology. 2006 Dec;113(12):2285-91. doi: 10.1016/j.ophtha.2006.05.062. Epub 2006 Sep 25.
PMID: 16996612BACKGROUND

MeSH Terms

Conditions

Myopia, DegenerativeMyopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

Gregory Ostrow, MD
Scripps Health
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

June 19, 2018

Primary Completion

January 9, 2023

Study Completion

January 9, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing: Will not share

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations