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NCT00802776 · ClinicalTrials.gov registry record · NA
Femtosecond Laser Assisted Keratoplasty
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT00802776 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 24 participants.
The verdict
NCT00802776, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study 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 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.
Interventions
- PROCEDURE Femtosecond laser assisted keratoplasty
- PROCEDURE PKP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-10 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00802776
The ClinicalTrials.gov registry entry for NCT00802776 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Femtosecond laser assisted keratoplasty is the first listed.
NCT00802776 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00802776 about?
NCT00802776 is a clinical study titled "Femtosecond Laser Assisted Keratoplasty". 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 ...
What is the current status of trial NCT00802776?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2007-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT00802776?
The interventions under investigation include: Femtosecond laser assisted keratoplasty (PROCEDURE), PKP (PROCEDURE).
Who is sponsoring clinical trial NCT00802776?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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