This trial is active, not recruiting.

Condition keratoconus
Sponsor University of Michigan
Start date November 2007
End date March 2012
Trial size 24 participants
Trial identifier NCT01695811, FLAK-15615


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Femtosecond Laser-Assisted Keratoplasty
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by University of Michigan.