Effect of Atropine on Pupil Size and Quality of Vision

NCT06071260 | Unknown DMC

• 1 other identifier: Atropine2023-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 0.01% 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).

Conditions

Myopia, Progressive

Keywords

Myopia; Atropine; Eye drops; Quality of vision; Pupil size

Outcome Measures

Primary Outcomes (1)

• Change in pupil size

  Pupil size will be recorded before and after the administration of 0.01% atropine eye drop using the OPD-Scan III (NEIDEK, Japan) device.

  Baseline (before 0.01% atropine eye drop), 12 hours, 16 hours, and 20 hours.

Secondary Outcomes (2)

• Change in subjective quality of vision

  Baseline (before 0.01% atropine eye drop), 12 hours, 16 hours, and 20 hours.

• Change in high-order aberration

  Baseline (before 0.01% atropine eye drop), 12 hours, 16 hours, and 20 hours.

Study Arms (1)

Study group

EXPERIMENTAL

Participants will receive 0.01% atropine (0.1 mg/ml)

Drug: 0.01% atropine eye drop

Interventions

0.01% atropine eye drop DRUG

One drop of 0.01% atropine will be administered to both eyes before bedtime. Baseline parameters were measured before and after atropine application.

Also known as: Low concentration atropine

Study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110034, China

Location

Related Publications (5)

• Holden 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.

  PMID: 26875007 BACKGROUND

• Sankaridurg PR, Holden BA. Practical applications to modify and control the development of ametropia. Eye (Lond). 2014 Feb;28(2):134-41. doi: 10.1038/eye.2013.255. Epub 2013 Dec 6.

  PMID: 24310242 BACKGROUND

• Polling JR, Kok RG, Tideman JW, Meskat B, Klaver CC. Effectiveness study of atropine for progressive myopia in Europeans. Eye (Lond). 2016 Jul;30(7):998-1004. doi: 10.1038/eye.2016.78. Epub 2016 Apr 22.

  PMID: 27101751 BACKGROUND

• Chia 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.

  PMID: 26271839 BACKGROUND

• Cooper J, Eisenberg N, Schulman E, Wang FM. Maximum atropine dose without clinical signs or symptoms. Optom Vis Sci. 2013 Dec;90(12):1467-72. doi: 10.1097/OPX.0000000000000037.

  PMID: 24076540 BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: December 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 20, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)