Corneal OpacityLALAKNCT01579643
OCT-guided LALAK in Children
A study testing OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) and Penetrating Keratoplasty (KP) in people with Corneal Opacity, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The primary goal of the trial is to determine if laser-assisted lamellar anterior keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions, glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Corneal Opacity
- What is being tested?
- OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) and Penetrating Keratoplasty (KP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 31 Aug 2016
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Vision limited by opacity in the anterior 2/3 of the corneal stroma
- Posterior opacity and endothelial defect must be less than 1 mm in diameter
Who cannot join
- Presence of cataract
- Presence of adhesions of the iris or lens to the cornea
- Inability/unwillingness of parents to give informed consent
- Inability of parents to commit to required visits to complete the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Los Angeles
Los Angeles, California, 90027
About this study
Official title: Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children
The primary goal of the trial is to determine if laser-assisted lamellar anterior keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions, glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK).
Read the detailed description
There is a great need for lamellar keratectomy in the treatment of congenital opacities because the rejection rate in pediatric PK is 4-5 times higher than in adults. In addition, the intraocular inflammatory reaction in infants often leads to synechiae, glaucoma, and cataract. Because LALAK does not penetrate the eye and preserves the host endothelium, it could reduce the risk of these complications. Keratoplasty must be performed at this early age to prevent amblyopia.
In this study, OCT-guided LALAK will be performed in patients whose vision is limited by opacity in the anterior 2/3 of the cornea. The objective is to determine if LALAK will provide an equal or better visual outcome than traditional PK without the associated post-operative complications.
- Conditions
- Corneal Opacity
- Being tested
- OCT guided laser-assisted lamellar anterior keratoplasty (LALAK), Penetrating Keratoplasty (KP)
- Keywords
- cornea, opacity, congenital
- Medical subject headings
- Corneal Opacity, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)Procedure or surgery
- The top hat-shaped donor cornea graft with tapered brim will be cut using a femtosecond (fs) laser at the eye bank. An anterior diameter of 6.0 mm will be used. The depth of the anterior side cut will match the planned excimer ablation depth.
- The host cornea bed will be prepared with an excimer laser.
- Descemet's membrane will be peeled off the graft, and the graft sutured into the host bed.
Penetrating Keratoplasty (KP)Procedure or surgery
- A trephine is used to perform a full thickness cut of a round area of cornea from the both patient's and donor's cornea.
- The donor cornea is then sutured where the patient's cornea was.
| Study group | Role | What they receive |
|---|---|---|
| LALAK | Experimental | Not described Receives: Procedure: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) |
| Penetrating Keratoplasty (KP) | Active comparator | Not described Receives: Procedure: Penetrating Keratoplasty (KP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of LALAK patients with post operative complications compared to PK patients
Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).
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 posted18 Apr 2012 (estimated)
- Study startJan 2012
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal OpacityStudies 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
- 1 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, Children's Hospital Los Angeles
- Investigators
- Bibiana Reiser, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579643
- Sponsor's protocol ID
- OHSU IRB#00006612 LALAK Child
- Acronym
- LALAK
- Status last verified
- Apr 2018
- First submitted
- 3 Jan 2012
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 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 Children
- ClinicalTrials.gov ID
- NCT01579643
- Acronym / sponsor ID
- LALAK / OHSU IRB#00006612 LALAK Child
- Conditions
- Corneal Opacity
- Keywords
- cornea, opacity, congenital
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Study start
- Jan 2012
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 18 Apr 2012 (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 primary goal of the trial is to determine if laser-assisted lamellar anterior keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions, glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK).
Detailed description
There is a great need for lamellar keratectomy in the treatment of congenital opacities because the rejection rate in pediatric PK is 4-5 times higher than in adults. In addition, the intraocular inflammatory reaction in infants often leads to synechiae, glaucoma, and cataract. Because LALAK does not penetrate the eye and preserves the host endothelium, it could reduce the risk of these complications. Keratoplasty must be performed at this early age to prevent amblyopia.
In this study, OCT-guided LALAK will be performed in patients whose vision is limited by opacity in the anterior 2/3 of the cornea. The objective is to determine if LALAK will provide an equal or better visual outcome than traditional PK without the associated post-operative complications.
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: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) |
| Penetrating Keratoplasty (KP) | Active comparator | Procedure: Penetrating Keratoplasty (KP) |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Vision limited by opacity in the anterior 2/3 of the corneal stroma
- Posterior opacity and endothelial defect must be less than 1 mm in diameter
Key exclusion criteria (4 listed)
- Presence of cataract
- Presence of adhesions of the iris or lens to the cornea
- Inability/unwillingness of parents to give informed consent
- Inability of parents to commit to required visits to complete the study
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 |
|---|---|---|
| OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)1. The top hat-shaped donor cornea graft with tapered brim will be cut using a femtosecond (fs) laser at the eye bank. An anterior diameter of 6.0 mm will be used. The depth of the anterior side cut will match the planned excimer ablation depth. 2. The host cornea bed will be prepared with an excimer laser. 3. Descemet's membrane will be peeled off the graft, and the graft sutured into the host bed. | Procedure or surgery | LALAK |
| Penetrating Keratoplasty (KP)1. A trephine is used to perform a full thickness cut of a round area of cornea from the both patient's and donor's cornea. 2. The donor cornea is then sutured where the patient's cornea was. | Procedure or surgery | Penetrating Keratoplasty (KP) |
Primary outcome
Number of LALAK patients with post operative complications compared to PK patients
Time frame: 24 months
Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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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.
Bibiana Reiser, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) and Penetrating Keratoplasty (KP) in people with Corneal Opacity, run by Oregon Health and Science University at 1 site in United States.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early. Results are not available in the source record.
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?
Number of LALAK patients with post operative complications compared to PK patients (time frame: 24 months). 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 17 Apr 2018; AzTrials last refreshed its copy on 29 Oct 2026.