NCT01695811

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

4.3 years

First QC Date

September 27, 2012

Last Update Submit

January 16, 2015

Conditions

Keratoconus

Keywords

Keratoconus, PKP, femtosecond laser assisted keratoplasty

Outcome Measures

Primary Outcomes (1)

  • Surgical outcomes

    Wound healing, surgical complications, visual function and endothelial layer assessment

    1 day, 1 week, 1, 3, 6, 12, 18 and 24 months

Study Arms (2)

FLAK

FLAK

PKP

Retrospective

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects indicated for corneal transplant surgery

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..

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 (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Ophthalmology

Study Record Dates

First Submitted

September 27, 2012

First Posted

September 28, 2012

Study Start

November 1, 2007

Primary Completion

March 1, 2012

Study Completion

December 1, 2013

Last Updated

January 21, 2015

Record last verified: 2015-01