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A prospective randomized controlled clinical trial evaluating the adaptability and satisfaction of Stellest® 2.0 lenses and Stellest® frames in myopic children in China

A prospective randomized controlled clinical trial evaluating the adaptability and satisfaction of Stellest® 2.0 lenses and Stellest® frames in myopic children in China

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118154
Enrollment
Unknown
Registered
2026-02-02
Start date
2026-02-10
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myopia

Interventions

Experimental Group:Wear Highly aspherical lenslets target MAX +/- Frames
Control Group:Wear Highly aspherical lenslets target +/- Frames

Sponsors

Tianjin Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Ages 4-16, regardless of gender; 2. Diagnosed with simple myopia or myopia combined with astigmatism, with specific criteria as follows: (1) Spherical equivalent between -0.50D and -8.00D (inclusive); (2) Astigmatism = 0.0 LogMAR; 3. Able to understand the purpose of the study, voluntarily participate, and sign the informed consent form either by the subject or their legal guardian, and able to complete follow-ups on time.

Exclusion criteria

Exclusion criteria: 1. Suffering from various eye diseases that require further treatment, including but not limited to: various acute or chronic eye inflammations, abnormal corneal sensitivity, keratoconus, corneal endothelial abnormalities, manifest strabismus, glaucoma, ocular hypertension (intraocular pressure >21 mmHg), eye tumors, pterygium, retinal detachment, or severe diseases of the ocular adnexa; 2. History of ophthalmic surgery, including corneal refractive surgery; 3. History of ocular trauma; 4. Currently using or planning to use during the study medications that may affect the wearing of rigid contact lenses, cause dry eye, affect vision or corneal curvature, or alter normal ocular physiology [such as immunosuppressants, glucocorticoids, intraocular pressure-lowering drugs, mydriatics (except for ophthalmic examination), miotics, etc.]; 5. Currently undergoing or previously received other myopia control interventions (including but not limited to orthokeratology lenses, multifocal soft contact lenses, myopia control spectacles, low-concentration atropine eye drops, etc.); 6. Other conditions deemed by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Subjective adaptation of lenses;

Secondary

MeasureTime frame
High- and low-contrast visual acuity;Binocular contrast sensitivity;Change in spherical equivalent;Axial length change;Choroidal thickness change;Subjective adaptation of frames;

Countries

China

Contacts

Public ContactLihua Li

Tianjin Eye Hospital

tysgzxlccs@163.com+86 22 2731 3336

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026