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临床试验/NCT02454920
NCT02454920已完成不适用

Measurement of the Distance Between the Limbus and Insertion of Extraocular Muscles Using Anterior Segment Optical Coherence Tomography

University of Miami0 个研究点目标入组 72 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
主要终点
Limbus to extraocular muscles insertion distance

研究概览

简要总结

Study designed to determine the ability and accuracy of anterior segment optical coherence tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the insertion site of the extraocular muscles (EOM) in adults with and without previous strabismus surgery. And to compare in surgical patients the pre-operative AS-OCT limbal-muscle insertion distance measurement to the intraoperative limbal-muscle insertion measurement using calipers (gold standard).

详细描述

The treatment of strabismus is often surgical. A better surgical plan would be possible if the exact limbus-insertion distance of the extraocular muscles was known. The clinical ophthalmologic examination, such as slit lamp biomicroscopy, cannot elucidate the muscle insertion position prior to surgery. This information is especially important in patients who have undergone prior strabismus surgery. In these patients, previous surgical data may not be available or the muscle insertion may be in a different location than expected. Thus, a preoperative imaging study that could accurately locate the muscle insertion may be useful for designing the surgical plan, possibly improving the success of the surgery, and reducing operative time and intraoperative complications.

Previous studies that used computed tomography (CT) scans and high-resolution magnetic resonance imaging (MRI), have failed to reliably detect the rectus muscle insertions. Ocular ultrasound allows anatomic visualization of the EOM, but has a low image resolution. Ultrasound biomicroscopy (UBM), can accurately measure the limbus-insertion distance, however, it induces significant measurement errors due to the pressure applied to the globe during examination. The recent advances in AS-OCT imaging allow non-invasive, detailed, cross-sectional examination of anterior segment structures by generating a two-dimensional high resolution image from a reflected light beam. Two previous studies have successfully used AS-OCT to analyze EOM insertions, but the number of participants was small and patients with previous strabismus muscle surgery were not included.

The investigators purpose is to gather limbus-EOM insertion distance data using the AS-OCT in a greater number of patients, include patients who have undergone previous strabismus procedures, and correlate AS-OCT measurements with intraoperative findings in those patients undergoing strabismus surgery.

Procedures

  1. After recruitment, a written consent will be obtained from subjects who agree to participate.
  2. A review of medical records will be performed to obtain demographics data, type of strabismus, history of previous eye surgery, etc (see Data Collection Sheet)
  3. AS-OCT imaging of the rectus muscles will be performed in all patients using the Visante (Visante AS-OCT; Carl Zeiss Meditec) and/or Heidelberg Spectralis (Spectralis AS-OCT; Heidelberg Engineering) instruments.
  4. For patients undergoing strabismus surgery, the distance from the corneoscleral limbus to the insertion site of the rectus muscles will be measured with calipers at the time of the surgery.
  5. After the surgery, AS-OCT imaging of the rectus muscles will be performed during routinely scheduled post-operative clinic visits.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • All patients age ≥ 18 years undergoing a strabismus evaluation at the Bascom Palmer Eye Institute will be invited to participate. Members of the study team will be involved in the clinical evaluation. The physician will determine if the patient has strabismus and whether strabismus surgery is advisable.

排除标准

  • Patient who is unwilling to participate the study.
  • A clinical scenario in which AS-OCT examination is not likely to be successful (e.g. an uncooperative patient).

结局指标

主要结局

Limbus to extraocular muscles insertion distance

时间窗: Baseline measurement

Measurement of the limbus to insertion distance with OCT

次要结局

  • Comparison between intra operative and OCT measurements of the distance from the limbus to extraocular muscles insertion(From date of baseline to date of surgery)

研究者

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

Hilda Capo

Professor of Clinical

University of Miami

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