Clinical trial NCT04464109: Comparative Motility of Alloplastic Orbital Implants
Official title: Comparative Motility of Retro-scleral and Intrascleral Orbital Implants After Evisceration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anophthalmos; Acquired
Evisceration; Traumatic, Eye
Keywords: Evisceration
Orbital implant
Implant position
Implant motility
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients who are candidates for evisceration

Exclusion Criteria:

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

Primary outcomes:
measure: Implant motility
timeFrame: 6 months
measure: Prosthesis motility
timeFrame: 6 months
Secondary outcomes:
measure: Volume augmentation
timeFrame: 6 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Mostafa Mohammed Mohammed Diab
Study officials:
affiliation: Fayoum University Hospitals
name: Mostafa Mohammed M Diab, PhD
role: PRINCIPAL_INVESTIGATOR
References: