Femtosecond Laser Assisted Keratoplasty

NCT00802776 | Completed

• 1 other identifier: HUM 15615-FLAK
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• Investigate postoperative physiology and biomechanics after Femtosecond Laser Assisted Keratoplasty in human eyes.

  Preoperatively and 1day, 1week and 1, 3, 6, 12, 18 and 24 months post operatively

Study Arms (2)

FLAK

ACTIVE COMPARATOR

Femtosecond laser assisted keratoplasty

Procedure: Femtosecond laser assisted keratoplasty

PKP

ACTIVE COMPARATOR

Penetrating Keratoplasty

Procedure: PKP

Interventions

Femtosecond laser assisted keratoplasty PROCEDURE

FLAK

PKP PROCEDURE

PKP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Cornea Clinic, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Shahzad Mian, MD

  University of Michigan Kellogg Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: erry J Bergstrom Collegiate Professor of Resident Education in Ophthalmology and Visual Sciences and Associate Professor of Oph, Ophthalmology & Visual Science

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2016
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)