the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression

NCT06034366 | Unknown DMC

• 1 other identifier: atropine2023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Near work-induced transient myopia (NITM) is an important factor in permanent myopia (PM) development and progression. Atropine eye drop is beneficial in reducing initial NITM and slowing down myopic progression.Participants were randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for one year. Initial NITM, cycloplegic refraction, axial length (AL), best-corrected visual acuity (BCVA), intraocular pressure (IOP), and pupil diameter will be measured at baseline, 4-week, 12-week, 24-week, 36-week, and 48-week. Visual Function Questionnaire was administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit. This study investigates the efficacy of 0.01% atropine in the treatment of NITM and its possible association with the progression of refractive change in Chinese myopic children.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Nearwork-induced transient myopia (NITM) in diopter

  WAM-5500; Grand Seiko, Japan, will be used to assess the NITM in diopter unit.

  At baseline, week 4, week 12, week 24, week 36, and week 48

Secondary Outcomes (3)

• Spherical equivalent (SE) in diopter

  At baseline, week 4, week 12, week 24, week 36, and week 48

• Axial length (AL) in millimetre

  At baseline, week 4, week 12, week 24, week 36, and week 48

• 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)

  At baseline, week 4, week 12, week 24, week 36, and week 48

Other Outcomes (3)

• Safety evaluation of best corrected visual acuity (BCVA)

  At baseline, week 4, week 12, week 24, week 36, and week 48

• Safety evaluation of pupil size

  At baseline, week 4, week 12, week 24, week 36, and week 48

• Safety evaluation of intraocular pressure

  At baseline, week 4, week 12, week 24, week 36, and week 48

Study Arms (2)

study group

EXPERIMENTAL

Participants in the study group will use 0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,

Drug: 0.01% atropine

placebo eye drops

OTHER

participants in the control group will utilize placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks.

Other: 0.9% sodium chloride

Interventions

0.01% atropine DRUG

0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,

study group

0.9% sodium chloride OTHER

placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks

placebo eye drops

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 to 12 years
• Subjects and their guardians agreed to participate in this study
• Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) or better.
• Initial NITM (spherical equivalent) ≤ -0.25 D
• Cycloplegic refractions ≥ -1.0 D and astigmatism ≤ 2.5 D in both eyes.
• Anisometropia in both eyes ≤ 1.5 D

You may not qualify if:

• Children with existing systemic diseases including asthma, collagen disease, immune system disorders, prostate hypertrophy, spastic paralysis, Down's syndrome, severe cardiac, pulmonary, hepatic, and renal dysfunction.
• Patients with glaucoma or high intraocular pressure, ocular inflammatory diseases, strabismus, amblyopia, corneal diseases, diseases of lens, retinal and optic neuropathy
• Regular use of medications that may affect the efficacy of 0.01% atropine, including hairy fruit rutabaga eye drops, tropicamide eye drops, anticholinergic drugs such as pirenzepine and tropicamide, and cholinergic drugs such as carbachol and hairy fruit rutabaga.
• Previous experiences with myopia control therapy.
• A history of allergies to atropine.
• Patients were deemed inappropriate for trial participation by the lead investigator.

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (2)

He Eye Hospital

Shenyang, Liaoning, 110034, China

RECRUITING

He Eye Specialist Hospital

Shenyang, 110034, China

RECRUITING

Related Publications (14)

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  PMID: 19553618 BACKGROUND

• Wong TY, Foster PJ, Hee J, Ng TP, Tielsch JM, Chew SJ, Johnson GJ, Seah SK. Prevalence and risk factors for refractive errors in adult Chinese in Singapore. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2486-94.

  PMID: 10937558 BACKGROUND

• Ciuffreda KJ, Vasudevan B. Nearwork-induced transient myopia (NITM) and permanent myopia--is there a link? Ophthalmic Physiol Opt. 2008 Mar;28(2):103-14. doi: 10.1111/j.1475-1313.2008.00550.x.

  PMID: 18339041 BACKGROUND

• Vera-Diaz FA, Strang NC, Winn B. Nearwork induced transient myopia during myopia progression. Curr Eye Res. 2002 Apr;24(4):289-95. doi: 10.1076/ceyr.24.4.289.8418.

  PMID: 12324868 BACKGROUND

• Lin Z, Vasudevan B, Ciuffreda KJ, Wang NL, Zhang YC, Rong SS, Qiao LY, Pang CC, Liang YB. Nearwork-induced transient myopia and parental refractive error. Optom Vis Sci. 2013 May;90(5):507-16. doi: 10.1097/OPX.0b013e31828deef1.

  PMID: 23538434 BACKGROUND

• Yam JC, Zhang XJ, Zhang Y, Wang YM, Tang SM, Li FF, Kam KW, Ko ST, Yip BHK, Young AL, Tham CC, Chen LJ, Pang CP. Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression (LAMP) Study: Continued Versus Washout: Phase 3 Report. Ophthalmology. 2022 Mar;129(3):308-321. doi: 10.1016/j.ophtha.2021.10.002. Epub 2021 Oct 7.

  PMID: 34627809 BACKGROUND

• 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: 32019700 BACKGROUND

• Guo L, Fan L, Tao J, Hua R, Yang Q, Gu H, Yu S, Li L, Zhao X. Use of Topical 0.01% Atropine for Controlling Near Work-Induced Transient Myopia: A Randomized, Double-Masked, Placebo-Controlled Study. J Ocul Pharmacol Ther. 2020 Mar;36(2):97-101. doi: 10.1089/jop.2019.0062. Epub 2019 Dec 3.

  PMID: 31800355 BACKGROUND

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

  PMID: 23303884 BACKGROUND

• Jimenez R, Redondo B, Galan T, Machado P, Molina R, Vera J. Impact of dual-focus soft contact lens wear on near work-induced transient myopia. Clin Exp Optom. 2023 Apr;106(3):296-302. doi: 10.1080/08164622.2022.2029684. Epub 2022 Jan 24.

  PMID: 35073496 BACKGROUND

• Chan CW, Wong D, Lam CL, McGhee S, Lai WW. Development of a Chinese version of the National Eye Institute Visual Function Questionnaire (CHI-VFQ-25) as a tool to study patients with eye diseases in Hong Kong. Br J Ophthalmol. 2009 Nov;93(11):1431-6. doi: 10.1136/bjo.2009.158428. Epub 2009 Jun 9.

  PMID: 19515645 BACKGROUND

• Miura M, Inomata T, Nojiri S, Sung J, Nagao M, Shimazaki J, Midorikawa-Inomata A, Okumura Y, Fujio K, Akasaki Y, Kuwahara M, Huang T, Nakamura M, Iwagami M, Hirosawa K, Fujimoto K, Murakami A. Clinical efficacy of diquafosol sodium 3% versus hyaluronic acid 0.1% in patients with dry eye disease after cataract surgery: a protocol for a single-centre, randomised controlled trial. BMJ Open. 2022 Jan 31;12(1):e052488. doi: 10.1136/bmjopen-2021-052488.

  PMID: 35105626 BACKGROUND

• Qin G, Chen J, Hu L, Qi Y, Xu L, He W, Yu S, Pazo EE, He X. Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China. BMJ Open. 2023 Dec 20;13(12):e079833. doi: 10.1136/bmjopen-2023-079833.

  PMID: 38128934 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Atropine; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 13, 2023
• Study Start: October 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (2)