Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of LALAK patients with post operative complications compared to PK patients
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
LALAK
干预措施: OCT guided laser-assisted lamellar anterior keratoplasty (LALAK) (Procedure)
Penetrating Keratoplasty (KP)
干预措施: Penetrating Keratoplasty (KP) (Procedure)
结局指标
主要结局
Number of LALAK patients with post operative complications compared to PK patients
时间窗: 24 months
Results of PK and LALAK will be compared in terms of corneal clarity, graft rejection, intraocular pressure, and vision (if measurable).
次要结局
未报告次要终点
研究者
David Huang
Bibiana Jin Reiser, MD: Assistant Professor of Clinical Ophthalmology
Children's Hospital Los Angeles