Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Progressive Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02721628
• Other study ID #: zoc-ekccl2015
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2016
• Last updated: March 22, 2016
• Start date: September 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2016
• Source: Sun Yat-sen University
• Contact: Xinbo Gao, MD, PHD
• Phone: +8613570942794
• Email: ice.freeport[@]163.com
• Is FDA regulated: No
• Health authority: China: Sun Yat-sen University
• Study type: Interventional

Clinical Trial Summary

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of Keratoconus

• Age = 18 years old

• Corneal thickness = 400 µm

• Progressive stage 1 to 3 keratoconus (Krumeich classification)

Exclusion Criteria:

• Corneal thickness < 400µm

• Concomitant corneal disease

• History of corneal surgery

Study Design

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

Related Conditions & MeSH terms

• Keratoconus
• Progressive Keratoconus

Intervention

Procedure:
• Epi-keratoplasty
Femtosecond laser assisted Epi-keratoplasty
• 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

Locations

Country	Name	City	State
China	ZhongShan Ophthalmic Center	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spherical equivalent		01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years	Yes
Primary	Changes of Spherical equivalent		01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years	Yes
Secondary	maximum keratometry (K-max) derived from computerized video keratography		01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years	Yes
Secondary	minimum keratometry	also from computerized video keratography, the opposite description of K-max	01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years	Yes
Secondary	Visual acuity		01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years	Yes