Comparative Motility of Alloplastic Orbital Implants

Evisceration; Traumatic, Eye Clinical Trial

Official title:

Comparative Motility of Retro-scleral and Intrascleral Orbital Implants After Evisceration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464109
• Other study ID #: R116/2020
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 2021

Study information

• Verified date: August 2020
• Source: Fayoum University Hospital
• Contact: Mostafa Mohammed M Diab, PhD
• Phone: 01016737314
• Email: mmd11[@]fayoum.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients who are candidates for evisceration

Exclusion Criteria:

• Inability to provide independent, informed consent

• Significant preoperative motility abnormalities

Related Conditions & MeSH terms

• Anophthalmos
• Anophthalmos; Acquired
• Evisceration; Traumatic, Eye

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	Mostafa Mohammed Mohammed Diab	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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