Comparative Motility of Alloplastic Orbital Implants
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- STATUS
- Recruiting
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- participants needed
- 30
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- sponsor
- Fayoum University Hospital
Summary
This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .
Description
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.
In this trial the investigators will try to study the effect of posterior placement of the implants on its motility after evisceration.
Details
Condition | Anophthalmos; Acquired, Evisceration; Traumatic, Eye |
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Age | 18years - 50years |
Treatment | Evisceration with orbital implantation |
Clinical Study Identifier | NCT04464109 |
Sponsor | Fayoum University Hospital |
Last Modified on | 5 August 2020 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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