NCT02721628

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Femtosecond Laser Assisted Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Detailed description

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.

Conditions

• Progressive Keratoconus

Interventions

Type	Name	Description
PROCEDURE	Epi-keratoplasty	Femtosecond laser assisted Epi-keratoplasty
PROCEDURE	Collagen Cross-Linking	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
DEVICE	Femtosecond laser	Use in the epic-keratoplasty surgery

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-12-01
• Completion: 2018-03-01
• First posted: 2016-03-29
• Last updated: 2016-03-29

Locations

1 site across 1 country: China