NCT04464109

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

July 5, 2020

Last Update Submit

August 1, 2020

Conditions

Anophthalmos; AcquiredEvisceration; Traumatic, Eye

Keywords

EviscerationOrbital implantImplant positionImplant motility

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Volume augmentation

    6 months

Study Arms (2)

Retro-scleral placement of the implant

ACTIVE COMPARATOR

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

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. 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

Interventions

Evisceration with orbital implantationPROCEDURE

Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.

Intrascleral placement of the implantRetro-scleral placement of the implant

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are candidates for evisceration

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mostafa Mohammed Mohammed Diab

Al Fayyum, Egypt

RECRUITING

MeSH Terms

Conditions

Anophthalmos

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mostafa Mohammed M Diab, PhD

    Fayoum University Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Mohammed M Diab, PhD

CONTACT

01016737314mmd11@fayoum.edu.eg

Richard C Allen, PhD

CONTACT

Richardcutlerallen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 5, 2020

First Posted

July 9, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available beginning 6 months after starting the trial and ending 12 months following article publication
Access Criteria
from corresponding author

Locations

EG(1)