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Completed Not applicable Interventional

Femtosecond Laser Assisted Keratoplasty

ClinicalTrials.gov ID: NCT00802776

Public ClinicalTrials.gov record NCT00802776. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 2:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparison of Femtosecond Laser-Assisted and Traditional Keratoplasty for Keratoconus

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00802776
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Michigan
Other
Enrollment
24 participants

Conditions and interventions

Conditions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2007
Primary completion
Nov 30, 2010
Completion
Dec 31, 2015
Last update posted
Mar 14, 2017

2007 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cornea Clinic, Kellogg Eye Center Ann Arbor Michigan 48105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00802776, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 14, 2017 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00802776 live on ClinicalTrials.gov.

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