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

NCT ID: NCT05448989

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. Among them, low-concentration atropine has few side effects and is the primary recommendation, but many clinical practices and studies suggest that its effect in controlling myopia is limited. 1% atropine ophthalmic drug has obvious curative effect advantages in 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 (eye instillation 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), data from retrospective clinical studies have shown that it can significantly reduce side effects and improve compliance, but there is currently a lack of evidence from prospective clinical studies. Therefore, this study intends to use a randomized controlled trial, with 1% atropine used in both eyes once a week as the control group, to evaluate the effect of the "5+3" regimen in controlling myopia (spherical equivalent and axial length), safety (accommodation amplitude, amount of phoria, binocular vision function, etc.), and the compliance and side effects (photophobia, blurred vision, etc.).

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1% atropine 5+3

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

Group Type: EXPERIMENTAL

1% atropine 5+3

Intervention Type: DRUG

A method for myopia control using high-concentration atropine

1% atropine weekly

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

Group Type: PLACEBO_COMPARATOR

1% atropine 5+3

Intervention Type: DRUG

A method for myopia control using high-concentration atropine

Interventions

1% atropine 5+3

A method for myopia control using high-concentration atropine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Xu, M.D.

Role: STUDY_DIRECTOR

Shanghai Eye Diseases Prevention Treatment Center

Locations

Shanghai Eye Diseases Prevention & Treatment Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Xu, M.D.

Role: CONTACT

drxuyan_2004@163.com

+86 18621080996

Facility Contacts

Haidong Zou, M.D.

Role: primary

zouhaidong@sjtu.edu.cn

+86 13311986528

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2021SQ001

Identifier Type: -

Identifier Source: org_study_id