Femtosecond Laser-Assisted Keratoplasty

NCT ID: NCT01695811

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study will be to determine optimal surgical technique for performing FLAK including laser parameters, keratoplasty shape and suture technique in order to standardize surgical technique and to collect safety and efficacy data. This will be compared to data of patients with full thickness PKP to measure visual outcomes, refraction, astigmatism, surgical methods and wound healing.

Detailed Description

FLAK Instrument: The Femtosecond Laser (IntraLase Corporation, Irvine, CA) is a focusable infrared laser, similar to the more familiar neodymium-yttrium-aluminum-garnet (YAG) laser, but uses shorter pulses in the hundred-femtosecond (100 X 10-15 seconds) duration range. There is minimal postoperative inflammation and collateral tissue damage.

Subjects: We will be enrolling subjects 18 years or older that need keratoplasty based on clinical findings. Subjects will be enrolled regardless of race or gender on a first come first serve basis. Subjects will be recruited from the physicians own clinic.

PKP Subjects: We will do a retrospective chart review on subjects who have undergone traditional PKP. FLAK eyes will be age and gender matched to these PKP eyes to compare visual outcomes, wound healing and complications.

Conditions

Keratoconus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

FLAK

FLAK

No interventions assigned to this group

PKP

Retrospective

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Corneal opacification.

2. Reduced ETDRS-measured, best corrected, distance visual acuity to 20/40 or worse.

3. Ability to participate in follow-up visits..

Exclusion Criteria

1. Corneal opacification adequately dense to obscure visualization of iris.

2. ETDRS-measured, best-corrected, distance visual acuity of 20/30 or better.

3. Corneal thickness greater than 1200 µm at the 9 mm peripheral zone.

4. Severe corneal thinning including descemetocoele with impending corneal rupture.

5. Prior PKP or incisional surgery that may provide a potential space into which the gas produced by the procedure can escape.

6. Poor visual potential in the non-study eye (VA of 20/100 or less, without potential for improvement by the examining ophthalmologist's judgment).

7. History of glaucoma, including steroid response rise in intraocular pressure.

8. Active intraocular inflammation or infection.

9. Age 18 or younger (consideration will be given to an upper age limit).

10. Unable to return for scheduled follow-up examinations.

11. Other medical condition(s) that will likely prevent long term follow-up.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Shahzad Mian

Professor, Department of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FLAK-15615

Identifier Type: -

Identifier Source: org_study_id