Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children

NCT04338373 | Unknown Phase 3

• 1 other identifier: 2020-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. This open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in Russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.

Conditions

Myopia

Keywords

myopia; low dose atropine; progressive myopia; atropine in non-asian population

Outcome Measures

Primary Outcomes (2)

• change in axial length

  Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data

  baseline - 12 months

• change in myopic progression rate

  Change in myopic progression rate measured as the difference between cycloplegic refraction from baseline to 12 months, compared with historical data.

  baseline - 12 months

Secondary Outcomes (3)

• change in difference between manifest and cycloplegic refractions

  baseline - 12 months

• change in positive relative accommodation

  baseline - 12 months

• tear production

  baseline - 12 months

Study Arms (1)

experimental

EXPERIMENTAL

0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes

Combination Product: 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)

Interventions

0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) COMBINATION_PRODUCT

nightly instillations of 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in both eyes for 12 months

experimental

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• myopia progression rate of 0.5D or more per year;
• myopia with astigmatism of 1.0D or less;
• axial length and cycloplegic refraction data obtained 6 months before recruiting or earlier
• signed informed consent.

You may not qualify if:

• congenital myopia;
• onset of myopia at 6 years old or earlier;
• allergic reactions to any eye drops in anamnesis;
• concomitant eye disorders, including strabismus.

Sponsors & Collaborators

• The V.P. Vyhodcev Eye Hospital: lead

Study Sites (1)

The V.P. Vyhodcev Eye Hospital

Omsk, 644024, Russia

RECRUITING

MeSH Terms

Conditions

Myopia; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open prospective clinical trial with historical control

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 8, 2020
• Study Start: February 17, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)