NCT01686906CompletedNot Applicable
Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus
Netherlands Institute for Innovative Ocular Surgery1 site in 1 country35 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Corneal power
Study Overview
Brief Summary
To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Advanced keratoconus
Exclusion Criteria
- •Further ophthalmic diseases
- •History of ocular surgery
- •Pregnancy, brest feeding
Arms & Interventions
Bowman layer graft implantation
Experimental
Intervention: Bowman layer graft implantation (Procedure)
Outcomes
Primary Outcomes
Corneal power
Time Frame: 2011-2020
Reduction and stabilizing of the corneal power after Bowman layer graft implantation
Secondary Outcomes
- Best corrected visual acuity(2011-2020)
Investigators
Study Sites (1)
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