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Evaluation of the Effectiveness and Safety of Hyperbolic Lens Telescope for Slowing the Progression of Myopia in Children - A Single-Center, Randomized, Controlled Clinical Trial Study

Evaluation of the Effectiveness and Safety of Hyperbolic Lens Telescope for Slowing the Progression of Myopia in Children - A Single-Center, Randomized, Controlled Clinical Trial Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078382
Enrollment
Unknown
Registered
2023-12-07
Start date
2023-12-07
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Myopia prevention and control

Interventions

Experimental Group 1:single vision + 20h telescope
Experimental Group 2:Defocus + 20h telescope
Control Group:Defocus only

Sponsors

Beijing Tongren Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1: The refractive status meets the following conditions: - After ciliary muscle paralysis, computerized refraction testing yields equivalent spherical power between -0.50D and -6.00D (inclusive) for both eyes. - After ciliary muscle paralysis, computerized refraction testing shows astigmatism =1.5D for both eyes. - After ciliary muscle paralysis, computerized refraction testing indicates refractive anisometropia =1.5D for both eyes. 2: IOP =21mmHg for both eyes. 3: Best corrected visual acuity is greater than or equal to 1.0 for both eyes. 4: The parent/guardian understands the protocol and is willing to enroll the participant in the randomized groups for hyperbolic surface telescope myopia intervention. 5: The patient understands and voluntarily agrees to participate in this study, and the informed consent form is signed by both the patient and the parent/guardian. 6: 6 = Age = 12 years old, gender unlimited.

Exclusion criteria

Exclusion criteria: 1: Allergic to the mydriatic drugs or their components used in this study. 2: Abnormalities in the refractive system of either eye, such as keratoconus, lenticonus, or spherophakia 3: Diseases that may affect refractive development or progress to high myopia, such as Down syndrome, Marfan syndrome, retinopathy of prematurity, and neonatal ischemic-hypoxic encephalopathy 4: Any eye with other ocular abnormalities or diseases affecting vision, such as ptosis, congenital corneal abnormalities, corneal leukoma, congenital lens abnormalities, cataract, macular lesions, choroidal lesions, severe vitreous opacity, or retinal disease 5: A history of glaucoma and/or shallow anterior chamber in either eye 6: History of manifest strabismus, amblyopia, or nystagmus, either past or present 7: History of eyelid, strabismus, intraocular, or refractive surgery, either past or present 8: Use of medications affecting efficacy evaluation systemically or locally within the 3 months prior to screening, such as anticholinergic drugs (e.g., atropine, tropicamide), antimuscarinic drugs (e.g., scopolamine), or drugs affecting pupil size and accommodation (e.g., belladonna extract, morphine, sedative-hypnotics) 9: Use of myopia control methods within the past month, including atropine or other antimuscarinic drugs, dual-focus/progressive or multifocal contact lenses, dual-focus/progressive or multifocal spectacle frames, corneal shaping lenses, rigid gas-permeable or other corneal contact lenses intended to reduce myopia progression 10: Past or present systemic diseases, including autoimmune diseases, central nervous system diseases, asthma, diabetes, severe cardiopulmonary dysfunction, severe hepatic or renal impairment 11: Clear family history of high myopia 12: Participation in other clinical trials within the month prior to randomization 13: Investigator's judgment that there are any other inappropriate conditions for participation in this trial.

Design outcomes

Primary

MeasureTime frame
diopter;Axis oculi;

Countries

China

Contacts

Public ContactLei Tian

Beijing Tongren Hospital Affiliated to Capital Medical University

tianlei0131@163.com+86 186 0016 6885

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026