Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-07-01
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Retro-scleral placement of the implant
Surgical steps;
1. Two anterior scleral relaxing incisions
2. A 360° scleral incision around the optic nerve to disinsert it
3. Two posterior scleral relaxing incisions
4. The implant is inserted posterior to posterior scleral edges
5. The posterior sclera is closed then the anterior sclera is overlapped and closed.
6. The implant is completely seated in the intraconal space
Evisceration with orbital implantation
Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.
Intrascleral placement of the implant
Anterior and posterior sclerotomies with the implant partly in the scleral shell and partly in the intraconal space.
1. Anterior relaxing sclerotomies not reaching the optic nerve
2. A 360° scleral incision around the optic nerve.
3. The anterior sclera flaps are overlapped and closed
4. Part of the implant remains in the scleral shell, while the remaining part is sitting in the intraconal space.
Evisceration with orbital implantation
Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.
Interventions
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Evisceration with orbital implantation
Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant preoperative motility abnormalities
18 Years
50 Years
ALL
No
Sponsors
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Fayoum University Hospital
OTHER
Responsible Party
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Mostafa Mohammed Mohammed Diab
Principal investigator
Principal Investigators
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Mostafa Mohammed M Diab, PhD
Role: PRINCIPAL_INVESTIGATOR
Fayoum University Hospitals
Locations
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Mostafa Mohammed Mohammed Diab
Al Fayyum, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R116/2020
Identifier Type: -
Identifier Source: org_study_id
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