Trial record 30 of 86 for:    cornea AND cross-linking

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Gao Xinbo, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02721628
First received: March 6, 2016
Last updated: March 22, 2016
Last verified: March 2016
  Purpose
Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Condition Intervention
Progressive Keratoconus
Procedure: Epi-keratoplasty
Procedure: Collagen Cross-Linking
Device: Femtosecond laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Femtosecond Laser Assisted Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Changes of Spherical equivalent [ Time Frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • minimum keratometry [ Time Frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years ] [ Designated as safety issue: Yes ]
    also from computerized video keratography, the opposite description of K-max

  • Visual acuity [ Time Frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Spherical equivalent [ Time Frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CCL

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02721628

Contacts
Contact: Xinbo Gao, MD, PHD +8613570942794 ice.freeport@163.com

Locations
China, Guangdong
ZhongShan Ophthalmic Center Recruiting
GuangZhou, Guangdong, China, 510060
Contact: Gao Xinbo, MD       ice.freeport@163.com   
Principal Investigator: Gao Xinbo, MD         
Sponsors and Collaborators
Sun Yat-sen University
  More Information

Responsible Party: Gao Xinbo, Attendant Doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02721628     History of Changes
Other Study ID Numbers: zoc-ekccl2015 
Study First Received: March 6, 2016
Last Updated: March 22, 2016
Health Authority: China: Sun Yat-sen University
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: undecided

Keywords provided by Sun Yat-sen University:
Keratoconus

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 21, 2016