NCT04395404

Brief Summary

Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

May 11, 2020

Last Update Submit

July 2, 2024

Conditions

Anophthalmos; AcquiredAnophthalmic Socket Syndrome

Outcome Measures

Primary Outcomes (3)

  • Displacement of orbital structures

    mm in x,y,z axis

    At least 5 years after enucleation or evisceration

  • Volumetric orbital difference

    ml

    At least 5 years after enucleation or evisceration

  • Surface comparisson of bony orbits

    mm

    At least 5 years after enucleation or evisceration

Study Arms (1)

Single arm

EXPERIMENTAL
Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

Patients with unilateral ASS, with and without the prosthesis in situ, are analysed by 3D- magnetic resonance imaging (MRI) with 64 channel head coil using T1 and T2 weighted, DIXON/ IDEAL, and T2 inversion recovery sequences.

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Unilateral anophthalmic socket syndrome (superior sulcus grading 0 till 4)
  • Enucleation/evisceration with primary implant more than 5 years ago
  • After informed consent

You may not qualify if:

  • MRI absolute and relative contraindications such as metallic fragments or metallic containing devices,
  • history of orbital trauma, previous anophthalmic socket and eyelid surgery, inflammation, infection, buphthalmos, congenital anophthalmos and radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Anophthalmos

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 20, 2020

Study Start

July 1, 2020

Primary Completion

November 1, 2020

Study Completion

February 28, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)