Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control

NCT05818033 | Completed

• 1 other identifier: 2023KYPJ005
• Study Type: interventional
• Target: 796
• Locations: 1 country
• Sites: 1

Brief Summary

China is a major country in myopia, with the highest number of teenagers suffering from myopia. Controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. Currently. There is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. Therefore, The researchers plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in Guangzhou, to test and verify the safety and effectiveness of CARE1.02 on myopia control compared with single-vision spectacle lens.

Conditions

Myopia

Keywords

Myopia control

Outcome Measures

Primary Outcomes (1)

• Changes of spherical equivalent refraction (SER) at one year

  The difference of SER at one year from baseline. SER will be measured after cycloplegia

  1 year

Secondary Outcomes (10)

• Changes of axial length (AL) at one year

  1 year

• Change of anterior chamber depth (ACD) at one year

  1 year

• Change of lens thickness (LT) at one year

  1 year

• Change of corneal curvature (CR) at one year

  1 year

• Best corrected visual acuity at one year

  1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

CARE1.02

Device: CARE1.02

Control group

ACTIVE COMPARATOR

Single-vision spectacle lens

Device: Single-vision spectacle lens

Interventions

CARE1.02 DEVICE

Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.

Intervention group

Single-vision spectacle lens DEVICE

Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.

Control group

Eligibility Criteria

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

You may qualify if:

• Aged 12 to 17 years;
• Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
• Best-corrected visual acuity of equal or better than 0.00 LogMAR (\>= 1.0 as Snellen).
• The intraocular pressure of 10 to 21mmHg.
• Volunteer to participate in this clinical trial with signature of the informed consent form.

You may not qualify if:

• History of eye injury or intraocular surgery;
• Clinically abnormal slit-lamp findings;
• Abnormal fundus examination;
• Ocular disease, such as uveitis and other inflammatory diseases,glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
• Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
• Participation of the drug clinical trial within three month and the device clinical trial within one month;
• Unable to have regular follow-up;
• Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (11)

• Irving EL, Yakobchuk-Stanger C. Myopia progression control lens reverses induced myopia in chicks. Ophthalmic Physiol Opt. 2017 Sep;37(5):576-584. doi: 10.1111/opo.12400. Epub 2017 Jul 26.

  PMID: 28746982 BACKGROUND

• Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

  PMID: 26875007 RESULT

• Naidoo KS, Fricke TR, Frick KD, Jong M, Naduvilath TJ, Resnikoff S, Sankaridurg P. Potential Lost Productivity Resulting from the Global Burden of Myopia: Systematic Review, Meta-analysis, and Modeling. Ophthalmology. 2019 Mar;126(3):338-346. doi: 10.1016/j.ophtha.2018.10.029. Epub 2018 Oct 17.

  PMID: 30342076 RESULT

• Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, Sankaridurg P, Saw SM, Trier K, Walline JJ, Wu PC, Wolffsohn JS. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M106-M131. doi: 10.1167/iovs.18-25958.

  PMID: 30817829 RESULT

• 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.

  PMID: 33811039 RESULT

• Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. doi: 10.1016/s0042-6989(98)00229-6.

  PMID: 10343811 RESULT

• Wallman J, Gottlieb MD, Rajaram V, Fugate-Wentzek LA. Local retinal regions control local eye growth and myopia. Science. 1987 Jul 3;237(4810):73-7. doi: 10.1126/science.3603011.

  PMID: 3603011 RESULT

• Tse DY, Lam CS, Guggenheim JA, Lam C, Li KK, Liu Q, To CH. Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5352-9. doi: 10.1167/iovs.07-0383.

  PMID: 18055781 RESULT

• Arumugam B, Hung LF, To CH, Sankaridurg P, Smith EL III. The Effects of the Relative Strength of Simultaneous Competing Defocus Signals on Emmetropization in Infant Rhesus Monkeys. Invest Ophthalmol Vis Sci. 2016 Aug 1;57(10):3949-60. doi: 10.1167/iovs.16-19704.

  PMID: 27479812 RESULT

• Tse DY, To CH. Graded competing regional myopic and hyperopic defocus produce summated emmetropization set points in chick. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8056-62. doi: 10.1167/iovs.10-5207.

  PMID: 21911586 RESULT

• Woods J, Guthrie SE, Keir N, Dillehay S, Tyson M, Griffin R, Choh V, Fonn D, Jones L, Irving E. Inhibition of defocus-induced myopia in chickens. Invest Ophthalmol Vis Sci. 2013 Apr 12;54(4):2662-8. doi: 10.1167/iovs.12-10742.

  PMID: 23471891 RESULT

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: April 25, 2023
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CN (1)