Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

October 5, 2018 updated by: Hai Yen Eye Care

Evaluation of Two-week Effects of 0.01%, 0.02% and 0.03% Atropine Eye Drops on Children Eyes With Myopia

To assess the two-week ocular responses, especially on pupillary size and accommodative amplitude, of nightly application of 0.01% or 0.02% or 0.03% atropine eye drops in children with myopia who were randomized to use of three different low-concentration atropine eye drops

Study Overview

Detailed Description

Atropine was proven to be effective in controlling myopia progression. However, the most common side effects of the use of atropine eye drop are dilation of pupil and decrease of accommodation. The investigators wish to evaluate the ocular responses of three low concentration atropine eye drops, 0.01% or 0.02% or 0.03%, mainly on the pupillary size and accommodative responses in children aged between 6 to 12 years old over two-week usage.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

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

      • Ho Chi Minh City, Vietnam, 700000
        • Department of Ophthalmology - An Sinh 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

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to read and comprehend Vietnamese and having parents or legal guardians who give informed consent as demonstrated by signing a record of informed consent.
  • Be between 6 and 12 years old, male or female.
  • Willing to apply eye drops once nightly at bedtime for two weeks 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 normal
  • No contact lens wearing history
  • 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 category S3 and above 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.

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.

  • 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.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 0.01% atropine eye drops
Participants will receive one drop per eye every night for two weeks
0.01% atropine sulphate
Active Comparator: 0.02% atropine eye drops
Participants will receive one drop per eye every night for two weeks
0.02% atropine sulphate
Active Comparator: 0.03% atropine eye drops
Participants will receive one drop per eye every night for two weeks
0.03% atropine sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pupillary diameter
Time Frame: at baseline, at three day and at two week
Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops
at baseline, at three day and at two week
Change in accommodative amplitude
Time Frame: at baseline, at three day and at two week
Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops
at baseline, at three day and at two week

Collaborators and Investigators

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

Collaborators

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.

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 (Actual)

March 8, 2018

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

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.

Clinical Trials on Myopia

Clinical Trials on 0.01% atropine eye drops

3
Subscribe