Condition category
Eye Diseases
Date applied
16/04/2020
Date assigned
24/04/2020
Last edited
03/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Hemangioma is a benign tumor that is found to grow within the orbit. Most commonly located behind the eye globe, it can push the eye forward causing eye-bulging doctors call proptosis.

The tumor can be removed through surgery entering via the lower eyelid (transconjunctival orbitotomy) using cryotherapy. Cryotherapy uses imaging guidance, a needle-like applicator called a cryoprobe, and liquid nitrogen or argon gas to create intense cold to freeze and destroy diseased tissue, including cancer cells.

The aim of this study is to evaluate the safety and efficacy of cryo-assisted transconjunctival orbitotomy for the extraction of intraconal cavernous hemangiomas.

Who can participate?
Patients with intraconal cavernous hemangiomas

What does the study involve?
The transconjunctival approach will be used for cryo-assisted lesion extraction. Cases will be followed for six months after the surgery.

What are the possible benefits and risks of participating?
Benefits: excision of the orbital tumors, avoid compression of the optic nerve and avoid exposure keratitis
Risks: trauma to the optic nerve, trauma to the globe, rupture of the mass and inability to remove the tumor

Where is the study run from?
Mansoura ophthalmic center (Egypt)

When is the study starting and how long is it expected to run for?
April 2017 to September 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Abd El Ghafar, aiman_eg_123@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ayman Abd El Ghafar

ORCID ID

http://orcid.org/0000-0002-5127-7558

Contact details

Ophthalmology Center
12 Gehan street
Mansoura
35516
Egypt
+20 (0)1005876138
ayman_gh@mans.edu.eg

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Transconjunctival cryo-assisted extraction of intraconal cavernous hemangioma

Acronym

Study hypothesis

is the transconjunctival cryo-assisted approach for excision of intraconal cavernous hemangioma is safe and effective?

Ethics approval

Approved 10/05/2017, Mansoura institutional review board (IRB) (Mansoura University Faculty of Medicine, Mansoura, Egypt; +20 (0)1092127930; IRB.MFM@hotmail.com), ref: R/17.05.26

Study design

Interventional non comparative single center case series

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Orbital intraconal cavernous hemangioma

Intervention

Excision of intraconal cavernous hemangiomas were performed through the transconjunctival approach assisted by the cryo-probe.

Patients enrolled were informed about the nature of surgery and benefits and possible complications of the procedure. they were admitted from May 2017 to August 2018 and followed for 6 months after surgery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

The success of the operation and complications measured using direct interview of patients after six months

Secondary outcome measures

None

Overall trial start date

02/04/2017

Overall trial end date

14/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients with intraconal cavernous hemangiomas

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

18

Participant exclusion criteria

Intraconal, non-compressible, solid lesions that simulate cavernous hemangioma e.g. schwannoma, solitary neurofibroma, and fibrous histiocytoma

Recruitment start date

14/05/2017

Recruitment end date

14/08/2018

Locations

Countries of recruitment

Egypt

Trial participating centre

Mansoura ophthalmic center
Gomhoria steet
Mansoura
35516
Egypt

Sponsor information

Organisation

Mansoura University

Sponsor details

Mansoura Ophthalmic Center
Mansoura Faculty of Medicine
Elgomhoria street
Mansoura
35516
Egypt
+20 (0)1000641607
aiman_eg_123@yahoo.com

Sponsor type

Hospital/treatment centre

Website

http://ophc.mans.edu.eg/

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

BMC ophthalmology journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

15/05/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/06/2020: The following changes have been made: 1. The recruitment start date has been changed from 02/05/2017 to 14/05/2017. 2. The overall trial start date has been changed from 02/03/2017 to 02/04/2017. 3. The overall trial end date has been changed from 05/05/2019 to 14/09/2018. 4. The plain English summary has been updated to reflect the changes above. 23/04/2020: Trial’s existence confirmed by Mansoura institutional review board.