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

Myopia Clinical Trial

Official title:

Safety and Effectiveness of CARE1.02 Spectacle Lens Versus Single-vision Spectacle Lens in Myopia Control: a Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05818033
• Other study ID #: 2023KYPJ005
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 760
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• Only one eye meets the inclusion criteria;

• 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• CARE1.02
Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.
• Single-vision spectacle lens
Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (11)

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 — View Citation

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-2020-3183 — View Citation

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.2 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of axial length (AL) at one year	The difference of AL at one year from baseline.	1 year
Secondary	Change of anterior chamber depth (ACD) at one year	The difference of ACD at one year from baseline.	1 year
Secondary	Change of lens thickness (LT) at one year	The difference of LT at one year from baseline.	1 year
Secondary	Change of corneal curvature (CR) at one year	The difference of CR at one year from baseline.	1 year
Secondary	Best corrected visual acuity at one year	Best corrected visual acuity	1 year
Secondary	Binocular visual function at one year	Binocular visual function	1 year
Secondary	Choroidal thickness at one year	The difference of Choroidal thickness at one year from baseline.	1 year
Secondary	Visual scale score at 1 year	Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2)	1 year
Secondary	Time length of wearing spectcales at one year	Time length of wearing spectcales collected every half year	1 year
Secondary	Safty of wearing the spectacle lens	Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations through symptoms and signs, intraocular pressure#slit lamp and ocular fundus checks.	1 year