Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

March 22, 2016 updated by: Gao Xinbo, Sun Yat-sen University

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

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center
        • Contact:
        • Principal Investigator:
          • Gao Xinbo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Epi-keratoplasty Group
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.
Procedure: Epi-keratoplasty
Femtosecond laser assisted Epi-keratoplasty
Device: Femtosecond laser
Use in the epic-keratoplasty surgery
ACTIVE_COMPARATOR: Collagen Cross-Linking Group
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
Procedure: 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
Other Names:
  • CCL

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum keratometry (K-max) derived from computerized video keratography
Time Frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
minimum keratometry
Time Frame: 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
01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Visual acuity
Time Frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years

Other Outcome Measures

Outcome Measure
Time Frame
Spherical equivalent
Time Frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (ESTIMATE)

March 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zoc-ekccl2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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