the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression
NCT ID: NCT06034366
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2023-10-01
2025-05-31
Brief Summary
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Detailed Description
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Near work, a main environmental-based factor in the development and progression of permanent myopia (PM), induced via near work-induced transient myopia (NITM). Compared with PM, NITM refers to the prolonged period required for the accommodation of the eyes to return to a normal level after engaging in a sustained near task. It was proposed some years ago that NITM, which produces minor and chronic retinal defocus, may be one of many possible environmentally-based, myopigenic, contributory factors to permanent myopia.
As a nonselective muscarinic antagonist, atropine eye drops with different concentrations have been reported to slow down the myopic progression in myopes. Recently, a two weeks study assessed the efficacy of a low-concentration of atropine (0.01%) on the initial NITM magnitude among Chinese myopic children. The results suggested 0.01% atropine reduced the initial NITM magnitude. However, the long-term efficacy of 0.01% atropine in treating NITM and the relationship between NITM and refractive change after treatment is still unclear.
This study aimed to investigate the efficacy of 0.01% atropine in treating NITM and its possible association with the progression of refractive change in Chinese myopic children.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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study group
Participants in the study group will use 0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,
0.01% atropine
0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,
placebo eye drops
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.
0.9% sodium chloride
placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks
Interventions
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0.01% atropine
0.01% atropine (3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks,
0.9% sodium chloride
placebo eye drops (0.9% sodium chloride, 3 ml unit-concentration, preservative-free) once nightly in both eyes for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
6 Years
12 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Locations
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He Eye Hospital
Shenyang, Liaoning, China
He Eye Specialist Hospital
Shenyang, , China
Countries
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Facility Contacts
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Emmanuel Eric Pazo, PhD
Role: primary
Qin Guanghao, MD
Role: backup
Emmanuel Eric Pazo
Role: primary
References
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Baird PN, Saw SM, Lanca C, Guggenheim JA, Smith Iii EL, Zhou X, Matsui KO, Wu PC, Sankaridurg P, Chia A, Rosman M, Lamoureux EL, Man R, He M. Myopia. Nat Rev Dis Primers. 2020 Dec 17;6(1):99. doi: 10.1038/s41572-020-00231-4.
He M, Huang W, Li Y, Zheng Y, Yin Q, Foster PJ. Refractive error and biometry in older Chinese adults: the Liwan eye study. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5130-6. doi: 10.1167/iovs.09-3455. Epub 2009 Jun 24.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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atropine2023
Identifier Type: -
Identifier Source: org_study_id