Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Sun Yat-sen University

Status: Unknown

Conditions: Progressive Keratoconus

Treatments: Device: Femtosecond laser; Procedure: Collagen Cross-Linking; Procedure: Epi-keratoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02721628

zoc-ekccl2015

Details and patient eligibility

About

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Epi-keratoplasty Group

Experimental group

Description:

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.

Treatment:

Procedure: Epi-keratoplasty

Device: Femtosecond laser

Collagen Cross-Linking Group

Active Comparator group

Description:

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

Treatment:

Procedure: Collagen Cross-Linking