CClinicalTrials.gg
Status unknownNCT05288335Updated Dec 28, 2022

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

An interventional study of Circular cylindrical mirror modulated frame glasses (compact) and Circular cylindrical mirror modulated frame glasses (strong defocus) in Myopia, sponsored by Tianjin Eye Hospital. Status unknown at 1 site in China. Open to participants aged 6 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by Tianjin Eye Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
6 Years to 13 Years
Sex
All
01

Study summary

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

Read the detailed 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.

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Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 240 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Tianjin Eye Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  1. Strabismus.
  2. Ocular and systemic abnormalities.
  3. Prior experience of myopia control.
  4. Only one eye meets the inclusion criteria.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Circular cylindrical mirror modulated frame glasses (compact)

    Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.

    Device: Circular cylindrical mirror modulated frame glasses (compact)

  • Experimental
    Circular cylindrical mirror modulated frame glasses (strong defocus)

    Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.

    Device: Circular cylindrical mirror modulated frame glasses (strong defocus)

  • Experimental
    single vision frame glasses

    Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.

    Device: single vision frame glasses

Interventions

  • DeviceCircular cylindrical mirror modulated frame glasses (compact)

    Circular cylindrical mirror modulated frame glasses (compact)

  • DeviceCircular cylindrical mirror modulated frame glasses (strong defocus)

    Circular cylindrical mirror modulated frame glasses (strong defocus)

  • Devicesingle vision frame glasses

    single vision frame glasses

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What researchers measure

Primary outcomes

  1. Changes in ocular axial length in a year

    The ocular axial length was measured by AL-scan

    Time frame: baseline, 12 months

Secondary outcomes

  1. Changes in cycloplegic objective spherical equivalent in a year

    The cycloplegic objective spherical equivalent was evaluated by a autorefractor

    Time frame: baseline, 12 months

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Study locations

1 site
  • Tianjin Eye Hospital
    Tianjin, 300020, China
08

References and documents

Publications

  • 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. PubMed 33811039 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05288335
Lead sponsor
Tianjin Eye Hospital
Responsible party
Sponsor
First posted
Mar 21, 2022
Start date
May 1, 2022
Primary completion
Oct 15, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Dec 28, 2022

Study contacts

Xiaoqin Chen, MD
principal investigator · Tianjin Eye Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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