Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia

NCT05448989 | Unknown Phase 4

• 1 other identifier: 2021SQ001
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. 1% atropine ophthalmic drug has obvious curative effect for controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine "5+3" myopia control program and 1% atropine alternate eye myopia control program. Retrospective clinical research data showed that it could significantly reduce side effects and improve use compliance, but there is currently no evidence from prospective clinical studies.

Conditions

Myopia

Outcome Measures

Primary Outcomes (12)

• spherical equivalent

  spherical equivalent(SE)，Diopter(D), measured by subjective optometry

  Before atropine treatment

• spherical equivalent

  spherical equivalent(SE)，Diopter(D), measured by subjective optometry

  1months after treatment

• spherical equivalent

  spherical equivalent(SE)，Diopter(D), measured by subjective optometry

  3months after treatment

• spherical equivalent

  spherical equivalent(SE)，Diopter(D), measured by subjective optometry

  6months after treatment

• spherical equivalent

  spherical equivalent(SE)，Diopter(D), measured by subjective optometry

  9months after treatment

• spherical equivalent

  spherical equivalent(SE)，Diopter(D), measured by subjective optometry

  12months after treatment

• axial length

  axial length(AL), millimeter(mm), measured by IOL master

  Before atropine treatment

• axial length

  axial length(AL), millimeter(mm), measured by IOL master

  1months after treatment

• axial length

  axial length(AL), millimeter(mm), measured by IOL master

  3months after treatment

• axial length

  axial length(AL), millimeter(mm), measured by IOL master

  6months after treatment

• axial length

  axial length(AL), millimeter(mm), measured by IOL master

  9months after treatment

• axial length

  axial length(AL), millimeter(mm), measured by IOL master

  12months after treatment

Secondary Outcomes (33)

• accommodation amplitude

  Before atropine treatment

• accommodation amplitude

  1months after treatment

• accommodation amplitude

  3months after treatment

• accommodation amplitude

  6months after treatment

• accommodation amplitude

  9months after treatment

Other Outcomes (54)

• lens thickness

  Before atropine treatment

• lens thickness

  1months after treatment

• lens thickness

  3months after treatment

Study Arms (2)

1% atropine 5+3

EXPERIMENTAL

Put the 1% atropine eye drops into the conjunctival sac, then close the eyes and press the nasolacrimal duct used for 5 consecutive nights in the first week of each month, one night per week in the 2nd, 3rd, and 4th weeks; after 3 months of monocular application, change to the contralateral eye Total treatment time 1 year

Drug: 1% atropine 5+3

1% atropine weekly

PLACEBO COMPARATOR

Put the 1% atropine eye drops into the conjunctival sac, then close the eyes and press the nasolacrimal duct once a week in both eyes Total treatment time 1 year

Drug: 1% atropine 5+3

Interventions

1% atropine 5+3 DRUG

A method for myopia control using high-concentration atropine

1% atropine 5+3; 1% atropine weekly

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 to 12 years old;
• Both eyes are in line with the diagnosis of myopic refractive error and 0.25D \< myopia spherical lens \<4.00D after mydriasis, astigmatism \<2.00D, binocular anisometropia \<3.00D, and the best corrected distance vision is at least 0.8, myopia The force is at least 0.8;
• Visual function: Timus≤100 seconds, exophoria \<5△, accommodation amplitude (AMP) ≥ age-related minimum accommodation amplitude value (minimum accommodation amplitude=15-0.25×age);
• No contraindications for atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.;
• The written informed consent of the guardian and the child himself.

You may not qualify if:

• History of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, fundus macular lesions or damage;
• Corneal curvature examination, the average K value of the anterior surface of the cornea is ≥45;
• Patients with ocular trauma, oblique or surgical eyes, atopic keratoconjunctivitis and other chronic eye diseases;
• Those with previous ophthalmia, severe angular, conjunctival infection and other eye diseases;
• Patients with neurological diseases and allergic or contraindications to atropine or other therapeutic drugs;
• Received other treatments to control the development of myopia in the past, such as the use of anticholinergic drugs such as atropine within 3 months, or participated in other relevant researchers such as functional frame mirrors and multifocal flexible mirrors;
• Other circumstances judged by the investigator to be unsuitable to participate in the research.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Diseases Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Yan Xu, M.D.

  Shanghai Eye Diseases Prevention Treatment Center

  STUDY DIRECTOR

Central Study Contacts

Yan Xu, M.D.

CONTACT

+86 18621080996; drxuyan_2004@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 8, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)