跳至主要内容
临床试验/NCT01243931
NCT01243931招募中不适用

Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK

研究概览

简要总结

Optical Coherence Tomography (OCT) machines are non-contact instruments that can measure the depth of scars and other causes of cloudiness in the front of the cornea. The purpose of this study is to determine whether OCT-guided settings for the lasers used for removal of corneal scars and other partial-thickness corneal defects result in improved vision in patients receiving these procedures.

详细描述

The long-term goal of this project is to utilize newly available very high-speed OCT technology to guide surgical treatments of corneas with superficial opacities and irregularities. OCT is well known for its exquisite resolution, but until recently it has not had sufficient speed to capture the shape of the cornea because of eye motion during OCT scanning. The development of Fourier-domain OCT (FD-OCT) technology has made the requisite speed possible.

Eyes with superficial opacities (corneal scars and stromal dystrophies) can be treated by phototherapeutic keratectomy (PTK). Currently, many surgeons rely on subjective slit-lamp impression of opacity depth to guide PTK and repeat slit-lamp examinations during surgery to determine if the opacity has been sufficiently reduced. Unpredictable hyperopic shifts can occur after PTK. The aim of this project is to develop methods for imaging the cornea with an FD-OCT system that will precisely measure corneal shape and use this information to guide surgery. Patients with irregularly shaped corneas could have their vision restored by reshaping the corneas with a procedure that combines the precision of OCT and lasers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with vision primarily limited by superficial opacities and irregularities that could be removed by PTK while leaving at least 250 µm.

排除标准

  • Inability to give informed consent
  • Inability to maintain stable fixation for OCT imaging
  • Inability to commit to required visits to complete the study
  • Deep corneal opacities and irregularities
  • Cataracts, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery

研究组 & 干预措施

Surgery

Experimental

OCT is assisting in surgery guidance.

干预措施: OCT-guided laser phototherapeutic keratectomy (Drug)

结局指标

主要结局

Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK

时间窗: 12 months post-procedure

The primary goal of the trial is to determine the efficacy of the OCT-guided PTK treatment of corneal opacities. During the course of the trial, we will compare the predictive accuracy of the original OCT-guided PTK planning system to the OCT topography-guided system. BSCVA will be measured in typical Snellen acuity notation as 20/xx (feet)

次要结局

  • Improvement in uncorrected visual acuity (UCVA), refractive error, and higher order aberrations(12 months post-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Huang

: David Huang, MD, PhD, Professor of Ophthalmology

Oregon Health and Science University

研究点 (1)

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