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Randomized, single blind, cross controlled clinical trial of the effectiveness and safety of rigid gas permeable contact lens (RGP) in controlling myopia progression

Randomized, single blind, cross controlled clinical trial of the effectiveness and safety of rigid gas permeable contact lens (RGP) in controlling myopia progression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067100
Enrollment
Unknown
Registered
2022-12-27
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

ametropia

Interventions

Experimental group:Wear lens A (D series) for both eyes, elute for 1 week after a year, and then wear lens B (Z series)
Control group:Wear lens B (Z series) for both eyes, elute for 1 week after a year, and then wear lens A (D series)

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) 6-14 years old, regardless of gender; (2) The diopter of computer optometry after bilateral ciliary muscle paralysis ranges from -1.00D to -10.00D (including -1.00D and -10.00D), astigmatism = -1.50D; (3) The best corrected visual acuity of binocular subjective optometry was = 0.8; (4) There were no other abnormalities or diseases in both eyes except for ametropia; (5) Tear film rupture time = 8 s, intraocular pressure 10-21 mmHg.

Exclusion criteria

Exclusion criteria: (1) The examination results indicate that there are contraindications or it is not suitable to wear rigid breathable contact lenses; (2) Suffering from diabetes, asthma, low immunity and other systemic diseases; (3) Systemic or local application of atropine and other drugs that may affect the development of ocular axis within one year; (4) Have used or are using specially designed myopic control lenses within one year (including defocusing frame glasses, OK glasses, defocusing lenses, etc.); (5) Corneal contact lens intolerance.

Design outcomes

Primary

MeasureTime frame
Computer optometry diopter;axial length;

Countries

China

Contacts

Public ContactYu Zhang

Peking University Third Hospital

1494867399@qq.com+86 13910071022

Outcome results

None listed

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