Study on the Effect of Two Ways of Cycloplegia on Biological Parameters of Ciliary Muscle

NCT05449015 | Unknown Phase 4

• 1 other identifier: 2022SQ006
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Atropine has a ciliary muscle-paralysing effect and causes hyperopic drift. Besides, atropine has been proven to slow the progression of myopia. Many studies have suggested that atropine can increase the thickness of the choroid. However, few studies have discussed changes in the ciliary muscle after treatment with atropine or other cycloplegic agents. This study aimed to assess the difference in ciliary muscle morphology before and after two different cycloplegic agents and to analyze the correlation between the changes of ciliary muscle biological parameters and the changes of eye axis, spherical equivalent, lens diopter, choroidal thickness, etc. One hundred and forty-four children would be randomly assigned 1:1 to the 1% atropine group and the tropicamide group. This study might provide clinical evidence for the role of regulatory factors in the occurrence and development of myopia.

Conditions

Accomodation; Refractive Errors; Myopia; Cycloplegia

Outcome Measures

Primary Outcomes (4)

• ciliary thickness parameters

  ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software

  before intervention

• ciliary thickness parameters

  ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software

  immediately after the last intervention

• the distance between ciliary muscle apex and scleral spur

  ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software

  before intervention

• the distance between ciliary muscle apex and scleral spur

  ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software

  immediately after the last intervention

Secondary Outcomes (4)

• spherical equivalent

  before intervention

• spherical equivalent

  immediately after the last intervention

• axial length

  before intervention

• axial length

  immediately after the last intervention

Other Outcomes (10)

• choroidal thickness

  before intervention

• choroidal thickness

  immediately after the last intervention

• lens thickness

  before intervention

Study Arms (2)

1% atropine

EXPERIMENTAL

1% atropine eye drops, in the conjunctival sac, once a night, for 7 days

Drug: 1% atropine

tropicamide

PLACEBO COMPARATOR

tropicamide eye drops, in the conjunctival sac, once every 5 minutes, after 3 consecutive doses, close eyes for 20 minutes

Drug: 1% atropine

Interventions

1% atropine DRUG

Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia

1% atropine; tropicamide

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ①Age 3 to 12 years old;
• Astigmatism \<2.00D, binocular anisometropia \<3.00D, and the best corrected distance visual acuity is at least 0.8, near vision at least 0.8;
• A clear anterior segment image can be obtained through anterior segment OCT;
• Have normal thinking and language communication skills, and can actively cooperate with the inspection process; ⑤ No contraindications to atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.; ⑥Written informed consent of the guardian and the child himself

You may not qualify if:

• ① Combined with neurological diseases and have allergies or contraindications to cycloplegic drugs or other drugs;
• Intraocular pressure ≥21mmHg; history of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, and retinal macular lesions or damage;
• Patients with chronic eye diseases such as ocular trauma and allergic conjunctivitis;
• Those who wear contact lenses and those who use myopia control-related drugs within 1 month; ⑤ Patients with previous varus trichiasis, severe horn, conjunctiva infection and other eye diseases;
• Insufficient image quality, such as inconsistent field of view, poor image exposure, inaccurate image focus, stains, shadows or crescent shadows, etc.;
• There are systemic diseases; ⑧ Epilepsy, mental disorders unable to communicate normally; ⑨ 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, 200080, China

RECRUITING

MeSH Terms

Conditions

Refractive Errors; Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Haidong Zou, 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: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 8, 2022
• Study Start: December 22, 2020
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)