Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Details

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

View Details

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	`NCT00567671` - Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia	Phase 2/Phase 3
Completed	`NCT00647699` - Corneal Collagen Cross-linking for Progressive Keratoconus	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