Status:
COMPLETED
Femtosecond Laser Assisted Keratoplasty
Lead Sponsor:
University of Michigan
Conditions:
Keratoconus
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Penetrating keratoplasty (PKP) is corneal transplantation performed by using round trephine blades to create matched circumferential incisions in both the diseased cornea and the donor cornea. The don...
Detailed Description
Penetrating keratoplasty (PKP) or full-thickness corneal transplantation is a common and highly successful method to restore vision decreased by corneal opacification. Surgery is performed by using ro...
Eligibility Criteria
Inclusion
- Corneal opacification.
- Reduced ETDRS-measured, best corrected, distance visual acuity to 20/40 or worse.
- Ability to participate in follow-up visits.
- Signed, informed consent.
Exclusion
- Corneal opacification adequately dense to obscure visualization of iris.
- ETDRS-measured, best-corrected, distance visual acuity of 20/30 or better.
- Corneal thickness greater than 1200 µm at the 9 mm peripheral zone.
- Severe corneal thinning including descemetocoele with impending corneal rupture.
- Prior PKP or incisional surgery that may provide a potential space into which the gas produced by the procedure can escape.
- Poor visual potential in the non-study eye (VA of 20/100 or less, without potential for improvement by the examining ophthalmologist's judgment).
- History of glaucoma, including steroid response rise in intraocular pressure.
- Active intraocular inflammation or infection.
- Age 18 or younger.
- Unable to return for scheduled follow-up examinations.
- Other medical condition(s) that will likely prevent long term follow-up.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00802776
Start Date
October 1 2007
End Date
January 1 2016
Last Update
March 15 2017
Active Locations (1)
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1
Cornea Clinic, Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105