Corneal Stroma Implantation for the Treatment of Keratoconus

Shandong Eye Hospital

Status: Unknown

Conditions: Keratoconus

Treatments: Procedure: corneal stroma implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03229239

20170717

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

corneal stroma implantation

Experimental group

Description:

implant the corneal stroma to the diseased cornea of keratoconus patients

Treatment:

Procedure: corneal stroma implantation