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Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
Keratoconus is a bilateral corneal ecstatic disease which is not uncommon and always behaves progressively and results in visual impairment by inducing irregular astigmatism and corneal opacities.
Collagen Cross-Linking (CXL) is widely used in progressive keratoconus. The cornea is soaked with a riboflavin solution and then being exposed to ultraviolet-A radiation. The performance creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. However, the effectiveness is not satisfied and accompanied with risks of side effects and serious complications, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, infection and stromal opacity due to corneal scarring.
Epi-keratoplasty is a reversible technique in which a corneal graft is transplanted on the recipients' eye with only removal of the epithelium of the receptor cornea. The procedure was assisted by femtosecond laser which allows precisely and neatly cutting. The graft strengths the whole host corneal rigidity and roughness and therefore renders the progression of keratoconus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epi-keratoplasty Group | Experimental | Epi-keratoplasty Group: Reversible keratoplasty performed with only the removal of corneal epithelium of the host cornea. A donor graft is transplanted on the recipients' eye locating on the Bowman's layer. |
|
| Collagen Cross-Linking Group | Active Comparator | Collagen Cross-Linking: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epi-keratoplasty | Procedure | Femtosecond laser assisted Epi-keratoplasty |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Spherical equivalent | 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| maximum keratometry (K-max) derived from computerized video keratography | 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years | |
| minimum keratometry | also from computerized video keratography, the opposite description of K-max |
| Measure | Description | Time Frame |
|---|---|---|
| Spherical equivalent | 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinbo Gao, MD, PHD | Contact | +8613570942794 | ice.freeport@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZhongShan Ophthalmic Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| Collagen Cross-Linking |
| Procedure |
Collagen Cross-Linking: Standard procedure, which is descriptor bellows: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes |
|
|
| Femtosecond laser | Device | Use in the epic-keratoplasty surgery |
|
| 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years |
| Visual acuity | 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years |