Anophthalmos; Acquired, Evisceration; Traumatic, Eye
Conditions
Keywords
Evisceration, Orbital implant, Implant position, Implant motility
Brief summary
This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .
Detailed 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.
Interventions
PROCEDUREEvisceration with orbital implantation
Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.
Sponsors
Fayoum University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are candidates for evisceration
Exclusion criteria
* Inability to provide independent, informed consent * Significant preoperative motility abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant motility | 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 |
| Prosthesis motility | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume augmentation | 6 months | 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. |
Countries
Egypt
Contacts
Primary ContactMostafa Mohammed M Diab, PhD
Backup ContactRichard C Allen, PhD
Outcome results
None listed