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Clinical trial to evaluate the safety and efficacy of biologic mesh in ophthalmic surgery

Clinical trial to evaluate the safety and efficacy of biologic mesh in ophthalmic surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034661
Enrollment
Unknown
Registered
2020-07-13
Start date
2020-07-13
Completion date
Unknown
Last updated
2020-07-20

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

Conditions

Pathological myopia

Interventions

Sponsors

People's Hospital of Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 60 Years

Inclusion criteria

Inclusion criteria: A. 3~5 years old >= -5.00D or above, 6 years old >= -6.00D, 7 years old >= -7.00D, 8 years old >= -8.00D, 9 years old >= -9.00D, 10 years old or above myopia level >= -10.00D; B. For people under 20 years old, myopia increases >= -1.00d and axial length increases >= 0.45mm per year; C. People over 20 years old have myopia of -10.00D or above, and the ocular axis continues to increase every year; D. Myopia above 30 years old is above -10.00 d, accompanied by posterior retinal pole lesions of the fundus, including macular hemorrhage, macular hole, macular degeneration, retinal plica; E. Patients who have a checklist of ocular related data (eye axis, best corrected visual acuity, axial ratio, etc.) for three months or more before admission, and they should meet any one of A, B, C, D; F. Subjects can be enrolled if they meet any of the above criteria.

Exclusion criteria

Exclusion criteria: A. Having a definite history of eye trauma and eye surgery; B. Those who cannot tolerate anesthesia; C. Premature infants, twins or multiple births, low birth weight infants and other birth abnormalities; D. Combined glaucoma, cataract, keratoconus, corneal ptosis, congenital ptosis and other eye diseases; E. Acute or chronic inflammation or tumor in or around the eyeball; F. Simple myopia, non-axial myopia and myopia caused by other syndromes, such as Marfan syndrome and Stickler syndrome; G. Persons suffering from systemic serious diseases, such as leukaemia, collagen diseases, diabetes, nephrotic retinopathy, severe hypertension, etc.; H. Participants in other clinical trials within three months; I. Those who are considered unsuitable by the researcher; Subjects who meet any of the above criteria will not be enrolled.

Design outcomes

Primary

MeasureTime frame
Ocular axial length;

Secondary

MeasureTime frame
Equivalent degree of ball mirror;UCVA;Fundus lesions;Blood circulation in the posterior polar retina;

Countries

China

Contacts

Public ContactHongwei Deng

Shenzhen Eye Hospital

dhw110@126.com+86 0755-23959542

Outcome results

None listed

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