Effect of Atropine on Pupil Size and Quality of Vision

October 27, 2023 updated by: He Eye Hospital

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 treatment of atropine at a low concentration of 0.01% has been observed to effectively slow down the advancement of myopia, with a reduction rate ranging from 60% to 83%. The administration of a lesser dose of atropine demonstrates a decreased occurrence of undesirable effects in comparison to the administration of atropine at a high concentration of 1.0%. Nevertheless, it is crucial to acknowledge that even when present in low concentrations, atropine still exerts an influence on both pupil size and pupil responsiveness. This investigation employs a prospective cohort study design, in which a set of objective and subjective assessments will be carried out before and after the injection of 0.01% atropine for a duration of 18 hours. The main aim of this study is to determine the effects of a specific concentration of atropine on several factors, including: 1) visual acuity; 2) pupil diameter; 3) subjective perception of vision quality; and 4) intraocular pressure. The objective of this study is to examine the effects of the eye drops on ocular health and determine the degree of patient acceptance about their prospective use as a preventive measure for myopia. The researchers have a positive expectation that the administration of the drops will have minimal influence on the participants in terms of side effects. However, the outcomes of this study will provide valuable insights for children and patients in effectively managing the side effects associated with the use of atropine for myopia control.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110034
        • He Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Participants will receive 0.01% atropine (0.1 mg/ml)
Drug: 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.
Other Names:
  • Low concentration atropine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pupil size
Time Frame: Baseline (before 0.01% atropine eye drop), 12 hours, 16 hours, and 20 hours.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subjective quality of vision
Time Frame: Baseline (before 0.01% atropine eye drop), 12 hours, 16 hours, and 20 hours.
Subjective quality of vision will be recorded before and after the administration of 0.01% atropine eye drop.
Baseline (before 0.01% atropine eye drop), 12 hours, 16 hours, and 20 hours.
Change in high-order aberration
Time Frame: Baseline (before 0.01% atropine eye drop), 12 hours, 16 hours, and 20 hours.
Change in high-order aberration will be recorded before and after administering 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

December 20, 2023

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atropine2023-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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