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Clinical Trial Summary

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02721628
Study type Interventional
Source Sun Yat-sen University
Contact Xinbo Gao, MD, PHD
Phone +8613570942794
Email ice.freeport@163.com
Status Recruiting
Phase N/A
Start date September 2015
Completion date March 2018

See also
  Status Clinical Trial Phase
Completed NCT02883868 - Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency? N/A
Active, not recruiting NCT04427956 - Corneal Crosslinking Treatment Study Phase 4
Terminated NCT01868620 - Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus. N/A
Recruiting NCT05314738 - Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus Phase 1/Phase 2
Not yet recruiting NCT06450470 - Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus Phase 3
Completed NCT02117999 - Transepithelial Corneal Cross-linking Using Iontophoresis N/A
Completed NCT01485211 - Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin Phase 4
Completed NCT04504578 - Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas N/A
Completed NCT00647699 - Corneal Collagen Cross-linking for Progressive Keratoconus Phase 3
Completed NCT00567671 - Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia Phase 2/Phase 3
Recruiting NCT00815256 - Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus Phase 3
Recruiting NCT04045626 - Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns N/A
Completed NCT03442751 - Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus Phase 3
Withdrawn NCT00679666 - Corneal Crosslinking in Keratoconus and Corneal Ectasia Phase 2/Phase 3
Completed NCT01411384 - Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus N/A
Not yet recruiting NCT00925327 - Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus Phase 2