Femtosecond Laser Assisted Keratoplasty
Completed · Not applicable
Conditions studied: Keratoconus
In brief
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 donor tissue graft is then secured in place with sutures which are usually removed postoperatively.The primary surgical goals are the preservation of a clear graft and improvement of vision. Surgical outcomes are limited by donor-recipient junction mismatch, astigmatism, rejection, infection and wound dehiscence. The femtosecond laser is a focusable, infrared laser capable of cutting tissue at various depths and in a range of patterns, and is currently being used to create corneal lamellar flaps in LASIK surgery. The laser parameters can be adjusted for submicron precision in cutting desired diameters, depths and shapes in the cornea, with minimal collateral injury. This technology is now capable of creating full-thickness corneal trephinations with customized locking edges at the graft-host junction between the donor and recipient corneas in Femtosecond Laser-Assisted Keratoplasty (FLAK). This approach may allow for better wound junction of the donor and recipient corneas, which in turn may also significantly reduce astigmatism, improve wound healing and visual recovery. This pilot study will help us determine optimal femtosecond laser spot size, separation, fluence, and energy which result in the best graft-host fit. The specific aim is to investigate postoperative physiology and biomechanics after FLAK in human eyes.
Key facts
- Study ID
- NCT00802776
- Run by
- University of Michigan
- People needed
- 24
- Starts
- 2007-10-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-03-15
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cornea Clinic, Kellogg Eye Center — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.