Comparative Motility of Alloplastic Orbital Implants

August 1, 2020 updated by: Mostafa Mohammed Mohammed Diab, Fayoum University Hospital

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

This study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are candidates for evisceration

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant motility
Time Frame: 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
6 months
Prosthesis motility
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume augmentation
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University Hospital

Investigators

  • Principal Investigator: Mostafa Mohammed M Diab, PhD, Fayoum University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

July 5, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 1, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R116/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available beginning 6 months after starting the trial and ending 12 months following article publication

IPD Sharing Access Criteria

from corresponding author

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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