Evaluation for risk of Human Corneal Stromal Lenticules from SMILE for Reuse

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900022228

Enrollment

Unknown

Registered

2019-03-30

Start date

2019-04-01

Completion date

Unknown

Last updated

2019-04-01

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

Conditions

None listed

Interventions

Fresh group:no

glycerol cryopreservation group:-78? anhydrous glycerol cryopreservation

decellularization group:0.1% sodium dodecylsulfate decellularization

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Diagnosed as "binocular ametropia", SMILE was performed in Tongren Hospital of Beijing to correct myopia, stable refraction with no more than 0.50 D changes annually for two years prior to surgery, no use of soft spherical contact lenses within one weeks, toric soft contact lenses and hard contact lenses within three weeks or orthokeratology contact lenses within three months preoperation.

Exclusion criteria

Exclusion criteria: Have ocular diseases except refraction error, history of prior ocular surgery or trauma, any systemic diseases, history of systemic hormones and immunosuppressive drugs, Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
bacterial culture;fungus culture;acanthamoeba culture;Herpes Simplex Virus Type1 detection;Herpes Simplex Virus Type 2 detection;VZV detection;CMV detection;EBV detection;AdV detection;immunohistochemistry;western blot;transmission electron microscope;transmittance;nanoindentation;	—

Countries

China

Contacts

Public ContactFengju Zhang

Beijing Tongren Hospital of Capital Medical University

zhangfj126@126.com+86 18601287753

Outcome results