Back to resultsEffect of Atropine on Pupil Size and Quality of Vision
Primary Purpose
Myopia, Progressive
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
0.01% atropine eye drop
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Progressive focused on measuring Myopia, Atropine, Eye drops, Quality of vision, Pupil size
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.
Sites / Locations
- He Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
Participants will receive 0.01% atropine (0.1 mg/ml)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in subjective quality of vision
Subjective quality of vision will be recorded before and after the administration of 0.01% atropine eye drop.
Change in high-order aberration
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06071260
Brief Title
Effect of Atropine on Pupil Size and Quality of Vision
Official Title
Short-term Effects of 0.01% Atropine on Adult Myopes Pupil Size and Subjective Quality of Vision
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
He Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This aims to investigated the short-term (10, 14, and 18 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 (10h, 14h, and 18h).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
Keywords
Myopia, Atropine, Eye drops, Quality of vision, Pupil size
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Participants will receive 0.01% atropine (0.1 mg/ml)
Intervention Type
Drug
Intervention Name(s)
0.01% atropine eye drop
Other Intervention Name(s)
Low concentration atropine
Intervention Description
One drop of 0.01% atropine will be administered to both eyes before bedtime. Baseline parameters were measured before and after atropine application.
Primary Outcome Measure Information:
Title
Change in pupil size
Description
Pupil size will be recorded before and after the administration of 0.01% atropine eye drop using the OPD-Scan III (NEIDEK, Japan) device.
Time Frame
Baseline (before 0.01% atropine eye drop), 10 hours, 14 hours, and 18 hours.
Secondary Outcome Measure Information:
Title
Change in subjective quality of vision
Description
Subjective quality of vision will be recorded before and after the administration of 0.01% atropine eye drop.
Time Frame
Baseline (before 0.01% atropine eye drop), 10 hours, 14 hours, and 18 hours.
Title
Change in high-order aberration
Description
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.
Time Frame
Baseline (before 0.01% atropine eye drop), 10 hours, 14 hours, and 18 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
He Eye Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110034
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26875007
Citation
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.
Results Reference
background
PubMed Identifier
24310242
Citation
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.
Results Reference
background
PubMed Identifier
27101751
Citation
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.
Results Reference
background
PubMed Identifier
26271839
Citation
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.
Results Reference
background
PubMed Identifier
24076540
Citation
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.
Results Reference
background
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Effect of Atropine on Pupil Size and Quality of Vision
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