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Efficacy and safety of paracentric hyperopic defocus RGP in the treatment of myopia

Efficacy and safety of paracentric hyperopic defocus RGP in the treatment of myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091175
Enrollment
Unknown
Registered
2024-10-22
Start date
2018-10-09
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

Myopia

Interventions

Experimental group:The patient wears a conventional design RGP in one eye and a defocus design RGP in the other eye. The wearing period is one year, and the type of lens worn in both eyes is changed a
Shaping lens control group:The patients in this group wore orthopedic lenses in both eyes.
paracenter defocus glasses control group:The patients in this group wore a paracentric defocus frame for both eyes.
monofocal glasses control group:The patients in this group wore monofocal glasses in both eyes.

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1) the age is 15 years old, regardless of gender. 2) myopia degree: greater than-2D, less than-9D (converted to RGP correction mode). 3) Corneal astigmatism is less than-1.50D or greater than-1.5D, but RGP is well positioned. 4) the best corrected visual acuity of both eyes was 1.0. 5) the intraocular pressure is in the normal range (10mmHg~21mmHg). 6) none of the subjects had received any correction modes, including plastic mirror, defocus soft mirror, defocus RGP and so on. 7) can cooperate with the observation of adverse events and curative effect. 8) the patients and their family members signed the informed consent form before joining the group.

Exclusion criteria

Exclusion criteria: 1 concomitant condition / disease of the eye 1.1 wearing other contact lenses within one month; 1.2 binocular problems such as strabismus; 1.3 ametropia and systemic diseases that affect visual acuity and myopia; 1.4 subjects with poor lens positioning. 1.5 there are acute keratoconjunctivitis, severe dry eyes, pterygium and other eye diseases and other contraindications to wear contact lenses. 2 systemic condition 2.1 systemic immune system diseases;2.2. long-term exposure to windy sand, high pollution and chemical environment; 2.3. people who have been engaged in intense and confrontational sports for a long time; 2.4. those with highly sensitive eyes who are unwilling to go through a week of adaptation or only exercise; 2.5. hyperthyroidism, diabetes and other systemic diseases that are not suitable to wear contact lenses. Mental patients ; 2.6. poor personal hygiene habits, unable to follow the prescribed nursing lenses. 3. compliance 3.1. patients violate the treatment plan, poor compliance, unable to cooperate with the observation of adverse events and efficacy;3.2. failure to follow the research or follow-up process

Design outcomes

Primary

MeasureTime frame
axial length;vision;Ocular surface health;Tear production;

Secondary

MeasureTime frame
diopter;Fundus health;Corneal thickness;Corneal endothelial cell density;

Countries

China

Contacts

Public ContactShujia Hou

The First Affiliated Hospital of Army Medical University

bengkui8919@sina.com+86 134 5282 5371

Outcome results

None listed

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