Femtosecond Laser-Assisted Keratoplasty (FLAK)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Michigan.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
Shahzad Mian, University of Michigan
First received: September 27, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Femtosecond Laser-Assisted Keratoplasty
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
subjects indicated for corneal transplant surgery
- Corneal opacification.
- Reduced ETDRS-measured, best corrected, distance visual acuity to 20/40 or worse.
- Ability to participate in follow-up visits..
- 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 (consideration will be given to an upper age limit).
- Unable to return for scheduled follow-up examinations.
- Other medical condition(s) that will likely prevent long term follow-up.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No publications provided
||Shahzad Mian, Professor, Department of Ophthalmology, University of Michigan
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 27, 2012
||September 27, 2012
||United States: Institutional Review Board
Keywords provided by University of Michigan:
Keratoconus, PKP, femtosecond laser assisted keratoplasty
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014