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Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Primary Purpose

Progressive Keratoconus

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Epi-keratoplasty

Collagen Cross-Linking

Femtosecond laser

About this trial

This is an interventional treatment trial for Progressive Keratoconus focused on measuring Keratoconus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

ZhongShan Ophthalmic CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Epi-keratoplasty Group

Collagen Cross-Linking Group

Arm 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.

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

Outcomes

Primary Outcome Measures

Changes of Spherical equivalent

Secondary Outcome Measures

maximum keratometry (K-max) derived from computerized video keratography

minimum keratometry

also from computerized video keratography, the opposite description of K-max

Visual acuity

Full Information

NCT ID

NCT02721628

First Posted

March 6, 2016

Last Updated

March 22, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02721628

Brief Title

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Progressive Keratoconus

Keywords

Keratoconus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Epi-keratoplasty Group

Arm Type

Experimental

Arm Description

Arm Title

Collagen Cross-Linking Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Epi-keratoplasty

Intervention Description

Femtosecond laser assisted Epi-keratoplasty

Intervention Type

Procedure

Intervention Name(s)

Collagen Cross-Linking

Other Intervention Name(s)

CCL

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Femtosecond laser

Intervention Description

Use in the epic-keratoplasty surgery

Primary Outcome Measure Information:

Title

Changes of Spherical equivalent

Time Frame