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The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| corneal stroma implantation | Experimental | implant the corneal stroma to the diseased cornea of keratoconus patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corneal stroma implantation | Procedure | During the operation,implant the corneal stroma to the diseased cornea of keratoconus. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingna Liu, researcher | Contact | 8613589089612 | lmn_2422@126.com | |
| Hua Gao, researcher | Contact | 8613705312702 | gaohua100@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiyun Shi, sponsor | director of shandong eye hosiptal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Eye Hospital | Recruiting | Jinan | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37171602 | Derived | Li N, Liu M, Tian G, Chen T, Lin Y, Qi X, Shi W, Gao H. Effects of femtosecond laser-assisted minimally invasive lamellar keratoplasty (FL-MILK) on mild-to-moderate and advanced keratoconus. Graefes Arch Clin Exp Ophthalmol. 2023 Oct;261(10):2873-2882. doi: 10.1007/s00417-023-06093-2. Epub 2023 May 12. |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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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 |