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临床试验/NCT04464109
NCT04464109Unknown不适用

Comparative Motility of Retro-scleral and Intrascleral Orbital Implants After Evisceration

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Prosthesis motility

研究概览

简要总结

This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .

详细描述

Evisceration allows removal of the intraocular contents while preserving the sclera and normal extraocular muscle attachments. It is more advantageous than enucleation in patients in whom intraocular tumor is rules out.

Maximizing orbital volume and restoration of movement are important aspects of a successful surgical outcome.

Standard evisceration techniques do not allow placement of an implant larger than 13-16 mm which don't adequately replace the volume leading to postevisceration socket syndrome. Therefore, various techniques have been described to expand the scleral cavity and allow placement of a large implant including anterior sclerotomies, posterior sclerotomies, and disinsertion of optic nerve.

Implant exposure is a terrible complication of evisceration with reported rates as high as 67%. Exposure of the implant can lead to infection, which usually mandates removal of the implant. Trying to minimize this risk, physicians intentionally place the implants posterior to the normal position of the globe. Some authors described placement of the implant posterior to posterior sclera which totally eliminated the risk of exposure.

However, this deep seating of the implant may have deleterious effects on its motility. It can decrease implant-prosthesis interaction. In addition, retro-scleral placement of the implant moves it posterior to the pulleys that serve as the functional origins of rectus muscles. This relationship would be expected to alter the pulling directions of the rectus muscles after evisceration hindering effective implant motility.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are candidates for evisceration

排除标准

  • Inability to provide independent, informed consent
  • Significant preoperative motility abnormalities

结局指标

主要结局

Prosthesis motility

时间窗: 6 months

It will be measured with the kestenbaum's limbus test. Photographs will be taken while patients wearing Kestenbaum spectacles in vertical and horizontal directions of gaze.

Implant motility

时间窗: 6 months

The conjunctiva is marked at the center point of the implant while the patient looking in primary gaze. The excursion of the mark will be measured will a standard millimeter ruler in extreme gaze positions

次要结局

  • Volume augmentation(6 months)

研究者

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

Mostafa Mohammed Mohammed Diab

Principal investigator

Fayoum University Hospital

研究点 (1)

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