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This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retro-scleral placement of the implant | Active Comparator | Surgical steps;
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| Intrascleral placement of the implant | Active Comparator | Anterior and posterior sclerotomies with the implant partly in the scleral shell and partly in the intraconal space.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evisceration with orbital implantation | Procedure | Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant motility | 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 | 6 months |
| Prosthesis motility | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Volume augmentation | Exophthalmometry will be performed for all patients after fitting a prosthesis. Enophthalmos is to be graded from 1 to 4 (grade 1 = no postoperative improvement; grade 2 = improvement <2 mm but remained enophthalmos; grade 3 = improvement ≥2 mm but remained enophthalmos; and grade 4 = no enophthalmos) compared with unaffected side. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa Mohammed M Diab, PhD | Contact | 01016737314 | mmd11@fayoum.edu.eg | |
| Richard C Allen, PhD | Contact | Richardcutlerallen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mostafa Mohammed M Diab, PhD | Fayoum University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mostafa Mohammed Mohammed Diab | Recruiting | Al Fayyum | Egypt |
The data that support the findings of this study will be available upon reasonable request from the corresponding author, after deidentification. The data are not publicly available due to their containing information that could compromise the privacy of research participants. Study protocol will be also available. Data will be available for researchers who provide a methodologically sound proposal.
Data will be available beginning 6 months after starting the trial and ending 12 months following article publication
from corresponding author
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| ID | Term |
|---|---|
| D000853 | Anophthalmos |
| ID | Term |
|---|---|
| D005124 | Eye Abnormalities |
| D005128 | Eye Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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