Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Not Applicable

• Conditions: Progressive Keratoconus
• Interventions: Procedure: Epi-keratoplasty; Procedure: Collagen Cross-Linking; Device: Femtosecond laser

• Registration Number: NCT02721628
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Study Timeline

• Study Start: 2015-09
• Status Verified: 2016-03
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-22
• Last Update Submitted: 2016-03-22
• Study First Posted: 2016-03-29
• Last Update Posted: 2016-03-29
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epi-keratoplasty Group	Epi-keratoplasty	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.
Epi-keratoplasty Group	Femtosecond laser	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.
Collagen Cross-Linking Group	Collagen Cross-Linking	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

Primary Outcome Measures

Name	Time	Method
Changes of Spherical equivalent	01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years

Secondary Outcome Measures

Name	Time	Method
maximum keratometry (K-max) derived from computerized video keratography	01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Visual acuity	01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
minimum keratometry	01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years	also from computerized video keratography, the opposite description of K-max

Trial Locations

Locations (1)

ZhongShan Ophthalmic Center; 🇨🇳 GuangZhou, Guangdong, China