The Effects of Low Dose Atropine on Choroidal Thickness

NCT03544827 | Completed Phase 4 FDA Drug

• 1 other identifier: 1168531-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Atropine eye drops are considered to be an effective form of myopia control in human eyes. However, the mechanism by which it exerts it effects are not fully understood. Thickening of the choroid subsequent to atropine administration may play an important role in the mechanisms by which atropine induces myopia control. Literature also notes that choroidal thickness undergoes diurnal variations, which is a variable that will be controlled in this study in order to examine atropine's effects on different baseline choroidal thicknesses. The purpose of the proposed study is to characterize better the influence of atropine on choroid thickness. The study aims are to:

1. 1.Determine the effect of low dose concentration of topical atropine (0.1% and 0.01%) on choroid thickness
2. 2.Determine the effect of topical atropine on choroid thickness in relationship to baseline thickness throughout the day and after one week of daily instillation

Conditions

Myopia

Keywords

Atropine

Outcome Measures

Primary Outcomes (1)

• Choroidal thickness

  Measure choroidal thickness changes at baseline and compare to choroidal thickness after intervention of atropine 0.01% and atropine 0.1%

  1 hour, 4 hours, 8 hours, and 1 week from baseline measurement

Secondary Outcomes (8)

• Visual acuity

  1 hour, 4 hours, 8 hours, and 1 week from baseline measurement

• Axial length

  1 hour, 4 hours, 8 hours, and 1 week from baseline measurement

• Lens thickness

  1 hour, 4 hours, 8 hours, and 1 week from baseline measurement

• Anterior chamber depth

  1 hour, 4 hours, 8 hours, and 1 week from baseline measurement

• Quality of Vision (QoV) Questionnaire

  1 hour, 4 hours, 8 hours, and 1 week from baseline measurement

Study Arms (2)

Atropine 0.01% then atropine 0.1%

EXPERIMENTAL

Participants will be on topical atropine 0.01% ophthalmic solution QD OU for 1 week (7 days) and then topical atropine 0.1% ophthalmic solution QD OU for 1 week (7 days) with a washout period of 4 weeks in between each intervention

Drug: Atropine

Atropine 0.1% then atropine 0.01%

EXPERIMENTAL

Participants will be on topical atropine 0.1% ophthalmic solution QD OU for 1 week (7 days) and then topical atropine 0.01% ophthalmic solution QD OU for 1 week (7 days) with a washout period of 4 weeks in between each intervention

Drug: Atropine

Interventions

Atropine DRUG

Atropine 0.01% then atropine 0.1%

Also known as: Atropine 0.01%, Atropine 0.1%

Atropine 0.01% then atropine 0.1%; Atropine 0.1% then atropine 0.01%

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 - 35 years
• Good general and ocular health
• Soft contact lens wearers to cease lens wear for at least 24 hours
• No previous rigid gas permeable lens wear
• Not taking monoamine oxidase inhibitors (MAOIs) and are not pregnant

You may not qualify if:

• History of ocular surgery, including refractive surgery
• Use of ocular medications
• Amblyopia
• Conditions where topical atropine is contraindicated
• Any eye or systemic disease that affect vision or refractive error

Sponsors & Collaborators

• State University of New York College of Optometry: lead

Study Sites (1)

SUNY College of Optometry

New York, New York, 10036, United States

Location

Related Publications (19)

• 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: 26271839 BACKGROUND

• Wallman J, Winawer J. Homeostasis of eye growth and the question of myopia. Neuron. 2004 Aug 19;43(4):447-68. doi: 10.1016/j.neuron.2004.08.008.

  PMID: 15312645 BACKGROUND

• 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: 26769180 BACKGROUND

• Siegwart JT Jr, Norton TT. The susceptible period for deprivation-induced myopia in tree shrew. Vision Res. 1998 Nov;38(22):3505-15. doi: 10.1016/s0042-6989(98)00053-4.

  PMID: 9893785 BACKGROUND

• Troilo D, Nickla DL, Wildsoet CF. Choroidal thickness changes during altered eye growth and refractive state in a primate. Invest Ophthalmol Vis Sci. 2000 May;41(6):1249-58.

  PMID: 10798638 BACKGROUND

• Hung LF, Wallman J, Smith EL 3rd. Vision-dependent changes in the choroidal thickness of macaque monkeys. Invest Ophthalmol Vis Sci. 2000 May;41(6):1259-69.

  PMID: 10798639 BACKGROUND

• Howlett MH, McFadden SA. Form-deprivation myopia in the guinea pig (Cavia porcellus). Vision Res. 2006 Jan;46(1-2):267-83. doi: 10.1016/j.visres.2005.06.036. Epub 2005 Aug 31.

  PMID: 16139323 BACKGROUND

• Howlett MH, McFadden SA. Spectacle lens compensation in the pigmented guinea pig. Vision Res. 2009 Jan;49(2):219-27. doi: 10.1016/j.visres.2008.10.008. Epub 2008 Dec 4.

  PMID: 18992765 BACKGROUND

• Woodman EC, Read SA, Collins MJ. Axial length and choroidal thickness changes accompanying prolonged accommodation in myopes and emmetropes. Vision Res. 2012 Nov 1;72:34-41. doi: 10.1016/j.visres.2012.09.009. Epub 2012 Sep 24.

  PMID: 23017772 BACKGROUND

• Chakraborty R, Read SA, Collins MJ. Monocular myopic defocus and daily changes in axial length and choroidal thickness of human eyes. Exp Eye Res. 2012 Oct;103:47-54. doi: 10.1016/j.exer.2012.08.002. Epub 2012 Aug 16.

  PMID: 22971342 BACKGROUND

• 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: 27713535 BACKGROUND

• Read SA, Alonso-Caneiro D, Vincent SJ, Collins MJ. Longitudinal changes in choroidal thickness and eye growth in childhood. Invest Ophthalmol Vis Sci. 2015 May;56(5):3103-12. doi: 10.1167/iovs.15-16446.

  PMID: 26024094 BACKGROUND

• Tan CS, Ouyang Y, Ruiz H, Sadda SR. Diurnal variation of choroidal thickness in normal, healthy subjects measured by spectral domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Jan 25;53(1):261-6. doi: 10.1167/iovs.11-8782.

  PMID: 22167095 BACKGROUND

• Chakraborty R, Read SA, Collins MJ. Diurnal variations in axial length, choroidal thickness, intraocular pressure, and ocular biometrics. Invest Ophthalmol Vis Sci. 2011 Jul 11;52(8):5121-9. doi: 10.1167/iovs.11-7364.

  PMID: 21571673 BACKGROUND

• North RV, Kelly ME. A review of the uses and adverse effects of topical administration of atropine. Ophthalmic Physiol Opt. 1987;7(2):109-14. doi: 10.1111/j.1475-1313.1987.tb01004.x.

  PMID: 2958765 BACKGROUND

• 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: 28494063 BACKGROUND

• Pediatric Eye Disease Investigator Group.. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2002 Mar;120(3):268-78. doi: 10.1001/archopht.120.3.268.

  PMID: 11879129 BACKGROUND

• McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.

  PMID: 20505205 BACKGROUND

• Rahman W, Chen FK, Yeoh J, Patel P, Tufail A, Da Cruz L. Repeatability of manual subfoveal choroidal thickness measurements in healthy subjects using the technique of enhanced depth imaging optical coherence tomography. Invest Ophthalmol Vis Sci. 2011 Apr 8;52(5):2267-71. doi: 10.1167/iovs.10-6024. Print 2011 Apr.

  PMID: 21087970 BACKGROUND

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Alexandra Benavente-Perez, PhD

  State University of New York College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and main investigator will be blinded to the allocation concealment
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal investigator

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 4, 2018
• Study Start: May 21, 2018
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)