An interventional study of Epi-keratoplasty and Collagen Cross-Linking in Progressive Keratoconus, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-29.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
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Exclusion Criteria:
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.
Procedure: Epi-keratoplasty · Device: Femtosecond laser
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
Procedure: Collagen Cross-Linking
Femtosecond laser assisted Epi-keratoplasty
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
Also known as: CCL
Use in the epic-keratoplasty surgery
Changes of Spherical equivalent
Time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
maximum keratometry (K-max) derived from computerized video keratography
Time frame: 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
Time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Visual acuity
Time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Spherical equivalent
Time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Plan to share: Undecided — undecided
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This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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