Status:
UNKNOWN
Effect of Atropine on Pupil Size and Quality of Vision
Lead Sponsor:
He Eye Hospital
Conditions:
Myopia, Progressive
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This aims to investigated the short-term (12, 16, and 20 h) effects of 0.01% atropine (0.1 mg/ml) on pupil size and subjective quality of vision in participants with myopia. Particpants will receive 0...
Detailed Description
The utilisation of atropine drops is a common practise in order to induce pupil dilatation, impede accommodation, and decelerate the advancement of myopia. Research findings indicate that the treatmen...
Eligibility Criteria
Inclusion
- Diagnosed with myopia
- Able to read and comprehend Chinese and willing to give informed consent as demonstrated by signing a record of informed consent.
- Be between 18 and 60 years old, male or female.
- Willing to apply eye drops once nightly at bedtime for one time and follow the clinical trial visit schedule as directed by the Investigator.
- Willing to answer the questionnaire about subjective measurements.
- Have ocular findings deemed to be myopic.
- No history of wearing contact lens.
- Vision correctable to at least 20/25 or better in each eye with spectacles.
Exclusion
- Any pre-existing ocular irritation, injury or condition, including infection or disease.
- Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. - - Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- Use of or a need for concurrent ocular medication at enrolment and/or during the clinical trial.
- Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
- History of eye surgery
- History of use of any myopia control interventions such as Orthokeratology, Rigid Permeable Contact Lenses Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- Currently treated with other interventions for myopia control
- Contraindications to atropine such as pulmonary disease, heart conditions and ADHD
- Known allergy or intolerance to ingredients to atropine eye-drops and other derivatives of anti-muscarinic receptor agents.
- Currently enrolled in another clinical trial.
- NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06071260
Start Date
December 1 2023
End Date
December 20 2023
Last Update
October 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
He Eye Hospital
Shenyang, Liaoning, China, 110034