STROMAL OPACITIESNCT01901601
LALAK for Opacities
A study testing LALAK, IEK and Retrobulbar Block or General Anesthesia in people with STROMAL OPACITIES, run by Oregon Health and Science University.
Trial summary
The purpose of this protocol is to compare and develop new surgical technique of partial-thickness corneal transplantation for treating corneal opacity. A newly developed technique, "dovetail" laser-assisted lamellar anterior keratoplasty (LALAK), will be tested and compared with standard full-thickness corneal… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- STROMAL OPACITIES
- What is being tested?
- LALAK, IEK and Retrobulbar Block or General Anesthesia
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eyes with corneal opacities that cannot be adequately or safely corrected with spectacles, contact lens or excimer laser surface ablation. The cornea must have healthy endothelium (endothelial cell density > 1,500/mm2).
Who cannot join
- Preoperative corneal thickness less than 400 microns.
- Inability to give informed consent.
- Corneal edema
- Central guttata
- Inability to maintain stable fixation for OCT imaging.
- Inability to commit to required visits to complete the study.
- Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
- Patients with severe collagen vascular diseases or ocular surface disorders
About this study
Official title: Randomized Clinical Trial of OCT-Guided Laser-Assisted Lamellar Anterior Keratoplasty in Adults for Stromal Opacities
The purpose of this protocol is to compare and develop new surgical technique of partial-thickness corneal transplantation for treating corneal opacity. A newly developed technique, "dovetail" laser-assisted lamellar anterior keratoplasty (LALAK), will be tested and compared with standard full-thickness corneal transplantation, Intralase-enabled keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea and does not have the risks associated with conventional IEK. Additionally, optical coherence tomography (OCT) will be used to guide the depth of the graft and donor dissections.
The data will be analyzed to understand whether the new technique (LALAK) can repeatedly achieve good visual outcomes with lower risk from the operation compared to the visual outcomes and risk associated with the current standard of care, IEK.
- Conditions
- STROMAL OPACITIES
- Being tested
- LALAK, IEK, Retrobulbar Block or General Anesthesia, optical coherence tomography (OCT), Topical Anesthesia
- Keywords
- KERATOPLASTY, STROMAL OPACITIES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LALAKProcedure or surgery
- 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. High-quality graft will be replaced in preservation medium and shipped to the surgeon prior to surgery.
- 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 femtosecond laser treatments will be performed under topical anesthesia in the laser suite. The femtosecond laser is an FDA-approved device for use in this indication (corneal transplantation including lamellar keratoplasty). A protective eye shield is placed over the eye. The graft will be sutured into the host bed.
IEKProcedure or surgery
- 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.
- 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 AnesthesiaDrug
optical coherence tomography (OCT)Device
OCT will be used to guide the depth of the graft and donor dissections. The OCT systems to be used in this study will be the RTVue (Optovue, Inc., Fremont, CA) or the Visante (Carl Zeiss Meditec, Inc., Dublin, CA). Both are FDA-approved for the mapping of corneal thickness.
Topical AnesthesiaDrug
femtosecond laserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| LALAK | Experimental | laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used. Receives: Procedure: LALAK; Drug: Retrobulbar Block or General Anesthesia; Device: optical coherence tomography (OCT); Drug: Topical Anesthesia; Device: femtosecond laser |
| IEK | Active comparator | Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used. Receives: Procedure: IEK; Drug: Retrobulbar Block or General Anesthesia; Device: femtosecond laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSCVA (Snellen chart)
A primary outcome measures will be BSCVA (Snellen chart)
Measured: 24 months
intraoperative perforation rate
A primary outcome measure will be intraoperative perforation rate.
Measured: 24 months
Secondary outcomes (5)
postoperative refractive error
A secondary outcome measures will be postoperative refractive error
Measured: 24 months
topographic astigmatism
A secondary outcome measures will be topographic astigmatism
Measured: 24 months
interface clarity
A secondary outcome measures will be interface clarity (masked OCT and confocal microscopy grading)
Measured: 24 months
endothelial cell count
A secondary outcome measures will be endothelial cell count (specular microscopy)
Measured: 24 months
complications
A secondary outcome measures will be complications (rejection, interface opacification, others).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Why it stopped: Modifying procedure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STROMAL OPACITIESStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Winston Chamberlain, MD, PhD, Principal investigator, Casey Eye Institute, Oregon Health & Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901601
- Sponsor's protocol ID
- OHSU IRB#00009282
- Other IDs
- R01EY018184
- Status last verified
- Apr 2018
- First submitted
- 2 Jul 2013
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of OCT-Guided Laser-Assisted Lamellar Anterior Keratoplasty in Adults for Stromal Opacities
- ClinicalTrials.gov ID
- NCT01901601
- Acronym / sponsor ID
- OHSU IRB#00009282
- Conditions
- STROMAL OPACITIES
- Keywords
- KERATOPLASTY, STROMAL OPACITIES
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Modifying procedure.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Study start
- Jul 2013
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to compare and develop new surgical technique of partial-thickness corneal transplantation for treating corneal opacity. A newly developed technique, "dovetail" laser-assisted lamellar anterior keratoplasty (LALAK), will be tested and compared with standard full-thickness corneal transplantation, Intralase-enabled keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea and does not have the risks associated with conventional IEK. Additionally, optical coherence tomography (OCT) will be used to guide the depth of the graft and donor dissections.
The data will be analyzed to understand whether the new technique (LALAK) can repeatedly achieve good visual outcomes with lower risk from the operation compared to the visual outcomes and risk associated with the current standard of care, IEK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LALAK | Experimental | Procedure: LALAK, Drug: Retrobulbar Block or General Anesthesia, Device: optical coherence tomography (OCT), Drug: Topical Anesthesia, Device: femtosecond laserlaser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used. |
| IEK | Active comparator | Procedure: IEK, Drug: Retrobulbar Block or General Anesthesia, Device: femtosecond laserIntralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes with corneal opacities that cannot be adequately or safely corrected with spectacles, contact lens or excimer laser surface ablation. The cornea must have healthy endothelium (endothelial cell density > 1,500/mm2).
Key exclusion criteria (8 listed)
- Preoperative corneal thickness less than 400 microns.
- Inability to give informed consent.
- Corneal edema
- Central guttata
- Inability to maintain stable fixation for OCT imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LALAK1. 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. High-quality graft will be replaced in preservation medium and shipped to the surgeon prior to surgery. 2. 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 femtosecond laser treatments will be performed under topical anesthesia in the laser suite. The femtosecond laser is an FDA-approved device for use in this indication (corneal transplantation including lamellar keratoplasty). A protective eye shield is placed over the eye. The graft will be sutured into the host bed. | Procedure or surgery | LALAK |
| IEK1. 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. 2. 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. | Procedure or surgery | IEK |
| Retrobulbar Block or General Anesthesia | Drug | IEK, LALAK |
| optical coherence tomography (OCT)OCT will be used to guide the depth of the graft and donor dissections. The OCT systems to be used in this study will be the RTVue (Optovue, Inc., Fremont, CA) or the Visante (Carl Zeiss Meditec, Inc., Dublin, CA). Both are FDA-approved for the mapping of corneal thickness. | Device | LALAK |
| Topical Anesthesia | Drug | LALAK |
| femtosecond laserThe 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. | Device | IEK, LALAK |
Primary outcome
BSCVA (Snellen chart)
Time frame: 24 months
A primary outcome measures will be BSCVA (Snellen chart)
intraoperative perforation rate
Time frame: 24 months
A primary outcome measure will be intraoperative perforation rate.
5 secondary outcomes
postoperative refractive error
Time frame: 24 months
topographic astigmatism
Time frame: 24 months
interface clarity
Time frame: 24 months
endothelial cell count
Time frame: 24 months
complications
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winston Chamberlain, MD, PhD principal investigator
Casey Eye Institute, Oregon Health & Science University
Questions about this trial
What is this clinical trial studying?
A study testing LALAK, IEK and Retrobulbar Block or General Anesthesia in people with STROMAL OPACITIES, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSCVA (Snellen chart) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.