Trial Outcomes & Findings for OCT-guided LALAK for KCN (NCT NCT01901614)

NCT ID: NCT01901614

Last Updated: 2019-01-23

Results Overview

The primary goal of the trial is to determine if LALAK can achieve the same level of postoperative Best Spectacle Corrected Visual Acuity (BSCVA) guided by OCT as IEK. The BSCVA will be measured using a clinic Snellen chart and recorded in the typical Snellen fraction (20/xx) in feet. This will be converted to logMAR form for statistical analysis.

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

24 months

Results posted on

2019-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Laser-assisted Lamellar Anterior Keratoplasty Laser-assisted lamellar anterior keratoplasty LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA).	Intralase-enabled Keratoplasty Intralase-enabled keratoplasty. IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Overall Study STARTED	3	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Laser-assisted Lamellar Anterior Keratoplasty Laser-assisted lamellar anterior keratoplasty LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA).	Intralase-enabled Keratoplasty Intralase-enabled keratoplasty. IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Screen Fail	1	0

Baseline Characteristics

OCT-guided LALAK for KCN

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 24 months

Population: For the LALAK group, there were 3 subjects enrolled, but one was a screen fail so no data was obtained for that subject.

Outcome measures

Outcome measures
Measure	Laser-assisted Lamellar Anterior Keratoplasty n=2 Participants LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty.	Intralase-enabled Keratoplasty n=2 Participants IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Does LALAK Achieve the Same Level of Post-operative BSCVA as IEK.	0.7 logMAR unit Interval 0.7 to 0.7	0.05 logMAR unit Interval -0.5853 to 0.6853

Adverse Events

Laser-assisted Lamellar Anterior Keratoplasty

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Intralase-enabled Keratoplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Laser-assisted Lamellar Anterior Keratoplasty n=2 participants at risk LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty.	Intralase-enabled Keratoplasty n=2 participants at risk IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Eye disorders Revert to keratoconus pattern	50.0% 1/2 • Number of events 1 • Data was collected up to 24-months from the date of surgery. See data tables for adverse event information.	0.00% 0/2 • Data was collected up to 24-months from the date of surgery. See data tables for adverse event information.
Eye disorders Corneal epithelial defect with interface haze	50.0% 1/2 • Number of events 1 • Data was collected up to 24-months from the date of surgery. See data tables for adverse event information.	0.00% 0/2 • Data was collected up to 24-months from the date of surgery. See data tables for adverse event information.

Additional Information

David Huang, MD, PhD

Oregon Health & Science University

Phone: 503-494-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Laser-assisted Lamellar Anterior Keratoplasty n=3 Participants LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty.	Intralase-enabled Keratoplasty n=2 Participants IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants