Corneal Stroma Implantation for the Treatment of Keratoconus

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

Detailed Description
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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.

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

Conditions
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Keratoconus

Intervention / Treatment
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* Procedure: corneal stroma implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced and completed keratoconus patients Voluntarily signed informed consent No surgery and anesthesia contraindications Exclusion Criteria: Acute edema of cornea Primary keratoconus patients The patients combined systemic diseases Reject study and follow visit Cannot tolerate surgery or anesthesia

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: corneal stroma implantation<br>implant the corneal stroma to the diseased cornea of keratoconus patients | Procedure: corneal stroma implantation<br>* During the operation,implant the corneal stroma to the diseased cornea of keratoconus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The best corrected visual acuity of the operated eye | To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery. | 1 month after operation | 
| The best corrected visual acuity of the operated eye | To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery. | 3 months after operation | 
| The best corrected visual acuity of the operated eye | To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery. | 6 months after operation | 
| The best corrected visual acuity of the operated eye | To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery. | 12 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The biomechanics of the operated eye | To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery. | 1 month after operation | 
| The biomechanics of the operated eye | To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery. | 3 months after operation | 
| The biomechanics of the operated eye | To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery. | 6 months after operation | 
| The biomechanics of the operated eye | To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery. | 12 months after operation |