Effect of Atropine on Pupil Size and Quality of Vision

• Status: Not yet recruiting
• Trial end date: 2023-12-20
• Target enrollment: 0
• Participant gender: All

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 0.01% 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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: He Eye Hospital
• Treatments: Atropine; Ophthalmic Solutions

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.