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New treatment option for Exotropia
Official title A-eyedrops on Ocular Alignment and Binocular Vision
ClinicalTrials.gov ID: NCT05379855
What this study is testing
What is 0.01% atropine eye drops?
0.01% atropine eye drops is an investigational medicine, being studied as a potential treatment for exotropia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 14
You may be able to join 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...
- Intraocular pressure \< 21mmHg;
- Ocular alignment fulfilling the following criteria：Exophoria with an exodeviation at near \> 6PD12; Intermittent exotropia with an exodeviation ≤25...
- people and their parents or legal guardians have signed informed consent and are willing to accept assigned by chance grouping and regular follow-up.
You likely can't join 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...
See the full eligibility criteria
- 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...
- people and their parents or legal guardians have signed informed consent and are willing to accept assigned by chance grouping and regular follow-up.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.