A-eyedrops on Ocular Alignment and Binocular Vision

NCT05379855 | Recruiting

• 1 other identifier: 2022C-PEDIG-Atropine
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

Brief Summary

Atropine is a non-selective muscarinic acetylcholine (M) receptor antagonist that paralyzes the ciliary muscle, dilates the pupil, and reduces the power of accommodation. Current studies have confirmed the effect of low concentrations of atropine drops in slowing the progression of myopia. In the atropine treatment for myopia (ATOM2) study, there was a rapid and dose-dependent decrease in accommodation after atropine drops: after 2 weeks of use, accommodation decreased from baseline 16.2D to 11.3D (4.9D) in the 0.01% atropine drops group, from baseline 16.7D to 3.8D (12.9D) in the 0.1% atropine group, and from baseline 15.8 D to 2.2 D (13.6 D) in the 0.5% atropine group; one year after withdrawal, there was some recovery of the accommodation in all the three groups, but it was still lower than the baseline values for each group, with a mean decrease of 2.56 D.Similar results were found in the Low-concentration Atropine for Myopia Progression (LAMP) Study by Janson C. Yam, 0.05% atropine drops reduced the accommodation by approximately 2D on average after 1 year of treatment. In general, if accommodation decreases by 2D or more compared to normal values, accommodation insufficiency is considered. There is a linkage between accommodation and convergence called accommodative convergence-to-accommodation (AC/A) which is closely related to exotropia. It was reported that the amount of accommodation required to maintain binocular fusion in patients with intermittent exotropia was greater than that of normal controls. In addition, pupil size and visual acuity are also factors that affect accommodation. In summary, the reduced accommodation amplitude, pupil dilation, and blurred near vision caused by atropine drops would affect the progression of intermittent exotropia and the ocular alignment after the surgery. In most cases, the reduced accommodation and convergence might induce exotropia, but in some patients, they may use more accommodative stimuli to compensate the insufficiency of accommodation, and there may be an increase in convergence or even esotropia. Taken together, due to the effect of atropine drops on pupil size, near visual acuity, and accommodation amplitude, the investigators hypothesize that atropine drops are likely to affect binocular vision and ocular alignment in patients with exotropia and exophoria.

Conditions

Exotropia; Exophoria; Myopia

Keywords

atropine; myopia; ocular alignment; binocular vision; exotropia; exophoria

Outcome Measures

Primary Outcomes (2)

• Refraction

  Change from baseline in spherical equivalent measured using cycloplegic autorefraction

  1 year and 2 years

• Axial length

  Change from baseline in Axial length measured using Optical Biometer

  1 year and 2 years

Secondary Outcomes (9)

• Stereopsis

  1 year and 2 years

• Fusion

  1 year and 2 years

• AC/A ratio

  1 year and 2 years

• Negative and positive relative accommodation

  1 year and 2 years

• Fusional convergence and divergence amplitudes

  1 year and 2 years

Study Arms (3)

0.05% atropine group

EXPERIMENTAL

Subjects received 0.05% atropine eye drops (0.1% sodium hyaluronate as a solution) both eyes once every night. Eye drops are prepackaged with identical eye drops bottle, pasted with number and shelf life, and stored in 4℃.

Drug: 0.05% atropine eye drops

placebo group

PLACEBO COMPARATOR

Subjects of the control group received placebo eye drops (0.1% sodium hyaluronate ophthalmic solution) both eyes once every night. Eye drops are prepackaged with identical eye drops bottle, pasted with number and shelf life, and stored in 4℃.

Drug: placebo eye drops (0.1% sodium hyaluronate ophthalmic solution)

0.01% atropine group

EXPERIMENTAL

Subjects received 0.01% atropine eye drops (0.1% sodium hyaluronate as a solution) both eyes once every night. Eye drops are prepackaged with identical eye drops bottle, pasted with number and shelf life, and stored in 4℃.

Drug: 0.01% atropine eye drops

Interventions

0.01% atropine eye drops DRUG

using 0.01% atropine eye drops for both eyes every night

0.01% atropine group

placebo eye drops (0.1% sodium hyaluronate ophthalmic solution) DRUG

using placebo eye drops (0.1% sodium hyaluronate ophthalmic solution) for both eyes every night

placebo group

0.05% atropine eye drops DRUG

using 0.05% atropine eye drops for both eyes every night

0.05% atropine group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The age ranged from 5 to 14 years;
• Astigmatism \< 2.5D, spherical power: - 1.00D \~ -6.00D; difference between eyes in spherical power \< 1.5D, difference between eyes in astigmatism \< 1.00D;
• Intraocular pressure \< 21mmHg;
• Ocular alignment fulfilling the following criteria：Exophoria with an exodeviation at near \> 6PD12; Intermittent exotropia with an exodeviation ≤25 PD both at distance and at near, Titmus \<=400 arc seconds; Intermittent exotropia patients underwent strabismus surgery, 6 months after operation, fulling the criteria of exophoria and intermittent exotropia mentioned before.
• Subjects and their parents or legal guardians have signed informed consent and are willing to accept randomized grouping and regular follow-up.

You may not qualify if:

• Amblyopia
• Have heart disease or serious respiratory disease
• Allergic to atropine, cyclopentantone, propoxybenzocaine and benzalkonium chloride;
• Those who have used contact lenses, bifocal lenses, or other measures to control myopia (including atropine);
• No binocular vision;
• Combined with vertical strabismus≥5PD, abnormal oblique muscle function≥ 2+, cyclodeviation, DVD or A-V pattern, paralytic and restrictive strabismus, comitant esotropia；
• Previous history of other ocular surgery;
• Severe complications during or after strabismus surgery, such as perforation of the sclera, tear and detachment of extraocular muscle; postoperative eye movement limitation; visual acuity decreased after operation;
• Combined with other ocular diseases;
• Craniofacial malformations affecting the orbits;
• significant neurological disorders;
• Birth less than 34 weeks or birth weight less than 1500 g;
• Intraocular pressure \> 21mmhg;
• Unable to cooperate with the examination.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye and ENT Hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (13)

• 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: 21963266 BACKGROUND

• 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: 24315293 BACKGROUND

• 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: 30514630 BACKGROUND

• Ha SG, Jang SM, Cho YA, Kim SH, Song JS, Suh YW. Clinical exhibition of increased accommodative loads for binocular fusion in patients with basic intermittent exotropia. BMC Ophthalmol. 2016 Jun 7;16:77. doi: 10.1186/s12886-016-0260-y.

  PMID: 27266700 BACKGROUND

• Jampolsky A. Ocular divergence mechanisms. Trans Am Ophthalmol Soc. 1970;68:730-822. No abstract available.

  PMID: 5524219 BACKGROUND

• Rutstein RP, Daum KM. Exotropia associated with defective accommodation. J Am Optom Assoc. 1987 Jul;58(7):548-54.

  PMID: 3668152 BACKGROUND

• Schor C, Horner D. Adaptive disorders of accommodation and vergence in binocular dysfunction. Ophthalmic Physiol Opt. 1989 Jul;9(3):264-8. doi: 10.1111/j.1475-1313.1989.tb00904.x.

  PMID: 2622666 BACKGROUND

• Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

  PMID: 26875007 BACKGROUND

• 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

• Chia A, Roy L, Seenyen L. Comitant horizontal strabismus: an Asian perspective. Br J Ophthalmol. 2007 Oct;91(10):1337-40. doi: 10.1136/bjo.2007.116905. Epub 2007 May 2.

  PMID: 17475715 BACKGROUND

• Chen X, Fu Z, Yu J, Ding H, Bai J, Chen J, Gong Y, Zhu H, Yu R, Liu H. Prevalence of amblyopia and strabismus in Eastern China: results from screening of preschool children aged 36-72 months. Br J Ophthalmol. 2016 Apr;100(4):515-9. doi: 10.1136/bjophthalmol-2015-306999. Epub 2015 Aug 10.

  PMID: 26261229 BACKGROUND

• Chen AH, O'Leary DJ, Howell ER. Near visual function in young children. Part I: Near point of convergence. Part II: Amplitude of accommodation. Part III: Near heterophoria. Ophthalmic Physiol Opt. 2000 May;20(3):185-98. No abstract available.

  PMID: 10897340 BACKGROUND

• Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus. 2006 Sep;14(3):147-50. doi: 10.1080/09273970600894716.

  PMID: 16950743 BACKGROUND

MeSH Terms

Conditions

Exotropia; Myopia

Condition Hierarchy (Ancestors)

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Refractive Errors

Central Study Contacts

Lianqun Wu, Doctor

CONTACT

+8613022110637; wulianqun19@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Department of Ophthalmology and Visual Science

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 18, 2022
• Study Start: March 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)