Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
NCT ID: NCT02721628
Last Updated: 2016-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-09-30
2018-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Epi-keratoplasty
Femtosecond laser assisted Epi-keratoplasty
Femtosecond laser
Use in the epic-keratoplasty surgery
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
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
Interventions
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Epi-keratoplasty
Femtosecond laser assisted Epi-keratoplasty
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
Femtosecond laser
Use in the epic-keratoplasty surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Corneal thickness ≥ 400 µm
* Progressive stage 1 to 3 keratoconus (Krumeich classification)
Exclusion Criteria
* Concomitant corneal disease
* History of corneal surgery
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Gao Xinbo
Attendant Doctor
Locations
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ZhongShan Ophthalmic Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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zoc-ekccl2015
Identifier Type: -
Identifier Source: org_study_id
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