ExotropiaNCT05379855
A-eyedrops on Ocular Alignment and Binocular Vision
A study testing 0.01% atropine eye drops and 0.05% atropine eye drops in people with Exotropia and Exophoria, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- What is being tested?
- 0.01% atropine eye drops and 0.05% atropine eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 339 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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；
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye and ENT Hospital, Fudan University
Shanghai
Lianqun Wu, MD
About this study
Official title: The Effects of Atropine Eyedrops on Ocular Alignment and Binocular Vision
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.
Read the detailed description
The prevalence of myopia in the world has exceeded 25% and is increasing year by year. Asia, especially China, is an area with high incidence of myopia. It is reported that the prevalence of myopia in children and adolescents in China was 53.6% in 2018. Low concentration atropine eye drops is one of the effective means to slow the progression of myopia. At present, low concentration atropine eye drops have been widely used in China, but its long-term efficacy and possible side effects still need to be studied.
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 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; after 1 year of discontinuation, 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 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, therefore the decrease of accommodation will also affect the binocular vision. Above all, the effect of atropine eye drops on pupil size, near visual acuity, amplitude of accommodation which is still impaired after 1 years' withdrawal, make us have many concerns and doubts about indications of atropine eye drops in children with strabismus or after the strabismus surgery.
Strabismus is a common eye disease in children, with an incidence rate of about 3%. It is reported that about 72% of strabismus cases in Asia are exotropia, of which intermittent exotropia is the most common type, and most cases are accompanied with myopia. It is found that patients with intermittent exotropia are often associated with abnormal accommodation. Ha SG 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 clarity are also factors affecting accommodation. In conclusion, atropine eye drops may affect the occurrence and development of intermittent exotropia by reducing the amplitude of accommodation, dilating pupils and blurred near vision. At the same time, the reduction of accommodation causes poor focusing and inappropriate afferent signals of the convergence system, which will lead to the fatigue of the convergence and divergence system, which may affect the ocular alignment of exotropia after 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.
In general, in China, myopia with exotropia or exophoria is a high incidence of eye disease in children, and low concentration atropine eye drops have been widely used to control the progression of myopia. It is urgent to carry out a large sample randomized controlled clinical trial to evaluate the impact of low concentration atropine on the ocular alignment and binocular vision of patients with exotropia and exophoria, and guide much safer application of the low concentration atropine eye drops.
- Being tested
- 0.01% atropine eye drops, placebo eye drops (0.1% sodium hyaluronate ophthalmic solution), 0.05% atropine eye drops
- Keywords
- atropine, myopia, ocular alignment, binocular vision, exotropia, exophoria
- Medical subject headings
- Exotropia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% atropine eye dropsDrug
using 0.01% atropine eye drops for both eyes every night
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
0.05% atropine eye dropsDrug
using 0.05% atropine eye drops for both eyes every night
| Study group | Role | What they receive |
|---|---|---|
| 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℃. Receives: 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℃. Receives: 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℃. Receives: Drug: 0.01% atropine eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refraction
Change from baseline in spherical equivalent measured using cycloplegic autorefraction
Measured: 1 year and 2 years
Axial length
Change from baseline in Axial length measured using Optical Biometer
Measured: 1 year and 2 years
Secondary outcomes (9)
Stereopsis
Change from baseline in stereopsis measured with the Random dot stereogram.
Measured: 1 year and 2 years
Fusion
Change from baseline in fusion measured with the Worth Four-Dots.
Measured: 1 year and 2 years
AC/A ratio
Change from baseline in AC/A ratio measured using the Von Graefe method
Measured: 1 year and 2 years
Negative and positive relative accommodation
Change from baseline in negative and positive relative accommodation measured using a phoropter.
Measured: 1 year and 2 years
Fusional convergence and divergence amplitudes
Change from baseline in fusional convergence and divergence amplitudes measured using a phoropter.
Measured: 1 year and 2 years
Accommodative facility
Change from baseline in accommodative facility measured using flip lens technique.
Measured: 1 year and 2 years
Accommodative amplitude
Change from baseline in accommodative amplitude measured using the minus lens techniques.
Measured: 1 year and 2 years
Near point of convergence
Change from baseline in near point of convergence measured using standard push-up technique.
Measured: 1 year and 2 years
Ocular alignment
Change from baseline in ocular alignment measured by a prism alternating cover test using an accommodative target at 6 m and 1/3 m.
Measured: 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start2 Mar 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ExotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Zhao, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379855
- Sponsor's protocol ID
- 2022C-PEDIG-Atropine
- Status last verified
- Feb 2025
- First submitted
- 24 Apr 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators concerns about patient privacy issues and it's better to protect the publication potential.
Publications
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.
PubMed 21963266Chia 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.
PubMed 24315293Yam 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.
PubMed 30514630Ha 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.
PubMed 27266700Jampolsky A. Ocular divergence mechanisms. Trans Am Ophthalmol Soc. 1970;68:730-822. No abstract available.
PubMed 5524219Rutstein RP, Daum KM. Exotropia associated with defective accommodation. J Am Optom Assoc. 1987 Jul;58(7):548-54.
PubMed 3668152Schor 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.
PubMed 2622666Holden 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.
PubMed 26875007Chia 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.
PubMed 26271839Chia 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.
PubMed 17475715Chen 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.
PubMed 26261229Chen 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.
PubMed 10897340Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus. 2006 Sep;14(3):147-50. doi: 10.1080/09273970600894716.
PubMed 16950743
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Atropine Eyedrops on Ocular Alignment and Binocular Vision
- ClinicalTrials.gov ID
- NCT05379855
- Acronym / sponsor ID
- 2022C-PEDIG-Atropine
- Keywords
- atropine, myopia, ocular alignment, binocular vision, exotropia, exophoria
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of myopia in the world has exceeded 25% and is increasing year by year. Asia, especially China, is an area with high incidence of myopia. It is reported that the prevalence of myopia in children and adolescents in China was 53.6% in 2018. Low concentration atropine eye drops is one of the effective means to slow the progression of myopia. At present, low concentration atropine eye drops have been widely used in China, but its long-term efficacy and possible side effects still need to be studied.
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 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; after 1 year of discontinuation, 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 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, therefore the decrease of accommodation will also affect the binocular vision. Above all, the effect of atropine eye drops on pupil size, near visual acuity, amplitude of accommodation which is still impaired after 1 years' withdrawal, make us have many concerns and doubts about indications of atropine eye drops in children with strabismus or after the strabismus surgery.
Strabismus is a common eye disease in children, with an incidence rate of about 3%. It is reported that about 72% of strabismus cases in Asia are exotropia, of which intermittent exotropia is the most common type, and most cases are accompanied with myopia. It is found that patients with intermittent exotropia are often associated with abnormal accommodation. Ha SG 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 clarity are also factors affecting accommodation. In conclusion, atropine eye drops may affect the occurrence and development of intermittent exotropia by reducing the amplitude of accommodation, dilating pupils and blurred near vision. At the same time, the reduction of accommodation causes poor focusing and inappropriate afferent signals of the convergence system, which will lead to the fatigue of the convergence and divergence system, which may affect the ocular alignment of exotropia after 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.
In general, in China, myopia with exotropia or exophoria is a high incidence of eye disease in children, and low concentration atropine eye drops have been widely used to control the progression of myopia. It is urgent to carry out a large sample randomized controlled clinical trial to evaluate the impact of low concentration atropine on the ocular alignment and binocular vision of patients with exotropia and exophoria, and guide much safer application of the low concentration atropine eye drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.05% atropine group | Experimental | Drug: 0.05% atropine eye dropsSubjects 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℃. |
| placebo group | Placebo comparator | Drug: placebo eye drops (0.1% sodium hyaluronate ophthalmic solution)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℃. |
| 0.01% atropine group | Experimental | Drug: 0.01% atropine eye dropsSubjects 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℃. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.01% atropine eye dropsusing 0.01% atropine eye drops for both eyes every night | Drug | 0.01% atropine group |
| placebo eye drops (0.1% sodium hyaluronate ophthalmic solution)using placebo eye drops (0.1% sodium hyaluronate ophthalmic solution) for both eyes every night | Drug | placebo group |
| 0.05% atropine eye dropsusing 0.05% atropine eye drops for both eyes every night | Drug | 0.05% atropine group |
Primary outcome
Refraction
Time frame: 1 year and 2 years
Change from baseline in spherical equivalent measured using cycloplegic autorefraction
Axial length
Time frame: 1 year and 2 years
Change from baseline in Axial length measured using Optical Biometer
9 secondary outcomes
Stereopsis
Time frame: 1 year and 2 years
Fusion
Time frame: 1 year and 2 years
AC/A ratio
Time frame: 1 year and 2 years
Negative and positive relative accommodation
Time frame: 1 year and 2 years
Fusional convergence and divergence amplitudes
Time frame: 1 year and 2 years
Accommodative facility
Time frame: 1 year and 2 years
Accommodative amplitude
Time frame: 1 year and 2 years
Near point of convergence
Time frame: 1 year and 2 years
Ocular alignment
Time frame: 1 year and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 21963266Chia 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.
- Background: PubMed 24315293Chia 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.
- Background: PubMed 30514630Yam 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.
- Background: PubMed 27266700Ha 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.
- Background: PubMed 5524219Jampolsky A. Ocular divergence mechanisms. Trans Am Ophthalmol Soc. 1970;68:730-822. No abstract available.
- Background: PubMed 3668152Rutstein RP, Daum KM. Exotropia associated with defective accommodation. J Am Optom Assoc. 1987 Jul;58(7):548-54.
- Background: PubMed 2622666Schor 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.
- Background: PubMed 26875007Holden 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.
- Background: PubMed 26271839Chia 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.
- Background: PubMed 17475715Chia 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.
- Background: PubMed 26261229Chen 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.
- Background: PubMed 10897340Chen 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.
- Individual participant dataSharing planned: No. The investigators concerns about patient privacy issues and it's better to protect the publication potential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.01% atropine eye drops and 0.05% atropine eye drops in people with Exotropia and Exophoria, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lianqun Wu, Doctor (+8613022110637, wulianqun19@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refraction (time frame: 1 year and 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05379855, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.