Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Myopia Clinical Trial

Official title:

Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05288335
• Other study ID #: TianjinEH-myopia progression
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2022
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia

Description:

Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.

Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

1. 6-13 years old;

2. SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;

3. Monocular best corrected visual acuity (VA) of 1.0 or better;

4. Acceptance of random group allocation and the masked study design

5. Voluntarily participate in the clinical trial and sign the informed consent;

Exclusion Criteria:

1. Strabismus.

2. Ocular and systemic abnormalities.

3. Prior experience of myopia control.

4. Only one eye meets the inclusion criteria.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (compact)
• Circular cylindrical mirror modulated frame glasses (strong defocus)
Circular cylindrical mirror modulated frame glasses (strong defocus)
• single vision frame glasses
single vision frame glasses

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in ocular axial length in a year	The ocular axial length was measured by AL-scan	baseline, 12 months
Secondary	Changes in cycloplegic objective spherical equivalent in a year	The cycloplegic objective spherical equivalent was evaluated by a autorefractor	baseline, 12 months