Corneal Stroma Implantation for the Treatment of Keratoconus

Implant the Corneal Stroma to the Diseased Cornea in Order to Cure Keratoconus

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03229239

Enrollment

Registered

2017-07-25

Start date

2017-08-11

Completion date

2018-12-31

Last updated

2017-08-24

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

Conditions

Keratoconus

Brief summary

The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.

Detailed description

Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma. The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc. The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is really a very big problem. In this pilot project, investigators would like to study whether corneal stroma implantation can increase the biomechanics of the cornea, which can, to some extent, delay the progress of keratoconus. This will allowed us to determine if useful data can be obtained, and if so, the donor cornea can be greatly saved.

Interventions

PROCEDUREcorneal stroma implantation

During the operation,implant the corneal stroma to the diseased cornea of keratoconus.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Advanced and completed keratoconus patients 2. Voluntarily signed informed consent 3. No surgery and anesthesia contraindications

Exclusion criteria

1. Acute edema of cornea 2. Primary keratoconus patients 3. The patients combined systemic diseases 4. Reject study and follow visit 5. Cannot tolerate surgery or anesthesia

Design outcomes

Primary

Measure	Time frame	Description
The best corrected visual acuity of the operated eye	1 month after operation	To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.

Secondary

Measure	Time frame	Description
The biomechanics of the operated eye	1 month after operation	To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.

Countries

China

Contacts

Primary ContactMingna Liu, researcher

lmn_2422@126.com8613589089612

Backup ContactHua Gao, researcher

gaohua100@126.com8613705312702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026