Trials / Terminated
TerminatedNCT01579643
OCT-guided LALAK in Children
Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- All
- Age
- 1 Month – 18 Years
- Healthy volunteers
- Not accepted
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).
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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 | 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. |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2016-08-31
- Completion
- 2016-08-31
- First posted
- 2012-04-18
- Last updated
- 2018-04-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01579643. Inclusion in this directory is not an endorsement.