Clinical trial

Short-term Effects of 0.01% Atropine on Adult Myopes Pupil Size and Subjective Quality of Vision

Name
Atropine2023-2
Description
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 0.01% atropine one drop to both eyes before bedtime. Baseline parameters were measured before atropine application. Changes in pupil sizes, under photopic and mesopic conditions, high-order aberration, and tear meniscus height were observed over the next day (12, 16, and 20 h).
Trial arms
Trial start
2023-12-01
Estimated PCD
2023-12-15
Trial end
2023-12-20
Status
Not yet recruiting
Treatment
0.01% atropine eye drop
One drop of 0.01% atropine will be administered to both eyes before bedtime. Baseline parameters were measured before and after atropine application.
Arms:
Study group
Other names:
Low concentration atropine
Size
40
Primary endpoint
Change in pupil size
Baseline (before 0.01% atropine eye drop), 12 hours, 16 hours, and 20 hours.
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-10-30

1 organization

1 product

2 indications

Organization
He Eye Hospital
Indication
Myopia
Indication
Progressive