Corneal Stroma Implantation for the Treatment of Keratoconus

Not Applicable

• Conditions: Keratoconus
• Interventions: Procedure: corneal stroma implantation

• Registration Number: NCT03229239
• Lead Sponsor: Shandong Eye Hospital

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.

Study Timeline

• Study First Submitted: 2017-07-16
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-25
• Status Verified: 2017-08
• Study Start: 2017-08-11
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-24
• Primary Completion: 2018-08-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
corneal stroma implantation	corneal stroma implantation	implant the corneal stroma to the diseased cornea of keratoconus patients

Primary Outcome Measures

Name	Time	Method
The best corrected visual acuity of the operated eye	12 months after operation	To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.

Secondary Outcome Measures

Name	Time	Method
The biomechanics of the operated eye	12 months after operation	To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.

Trial Locations

Locations (1)

Shandong Eye Hospital; 🇨🇳 Jinan, Shandong, China