Plain English Summary
Background and study aims
Eyes contain a jelly-like liquid called vitreous. When a patient is having surgery on their retina (the part of the eye where light signals are sent to the brain to create an image) this liquid has to be removed in order to gain access. This surgical procedure is known as a plars plana vitrectomy. During this procedure, vitreous needs to be replaced with a saline (salt water). In some cases, the retina can become detached from the eye and so silicone oil tamponade (gel) may be used to keep the retina in place. Silicone oil carries heat differently to water and these heat changes can lead to blurred vision. This study aims to compare eye temperature in participants who have an eye with silicone oil tamponade and an eye without it, in order to determine if silicone oil affects the temperature.
Who can participate?
Adults who are having a pars plana vitrectomy using silicone oil tamponade as part of their normal care.
What does the study involve?
The temperature of each participant’s cornea (the out layer of the eye) is measured using a handheld non-contact thermometer in both eyes. This involves shining a special light into the eye which measures the temperature. Three temperature readings from each eye are taken. Participants also have their overall body temperature (taken from their forehead) measured using the same method.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to those taking part in the study.
Where is the study run from?
Istanbul Education and Research Hospital (Turkey)
When is the study starting and how long is it expected to run for?
November 2015 to May 2016
Who is funding the study?
Investigator initiated and funded (Turkey)
Who is the main contact?
Dr. Erkan Unsal
erkanunsal@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Erkan Unsal
ORCID ID
http://orcid.org/0000-0002-5811-1550
Contact details
Istanbul Research and Training Hospital
Department of Ophthalmology
Kasap Ilyas Mah Org Abdurrahman Nafiz
Gurman Cad
Fatih
Istanbul
34098
Turkey
+90 505 238 22 50
erkanunsal@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Temperature effect of silicone oil at the anterior segment
Acronym
Study hypothesis
The aim of this study is to measure the temperature difference between eyes with and without silicone oil tamponade.
Ethics approval
Ethical Review Board of Istanbul Education and Research Hospital, 20/11/2015, ref: 2015-728
Study design
Observational single-centre cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Pars plana vitrectomy, intraocular silicone oil tamponade
Intervention
Participants have their central corneal eye temperature and their body temperature measured in a room with fixed temperature, humidity and illumination. To avoid inter-observer variations, all temperature measurements is done by a single examiner in the same examination room.
Central corneal temperatures are measured using a non-contact infrared thermometer from the corneal surface. The aiming beam of handheld infrared skin thermometer is centered slightly inferotemporally to the center of cornea. The working distance is the distance where the aiming beam formed a sharp concentric rings on the iris. Three measurements from each eye are taken and mean value for each eye is used for analysis.
Body temperature is measured using a non-contact infrared thermometer taken from the forehead. This device measures body temperature from 16 ºC to 40 ºC with a minimum accuracy of 0.2 ºC. Measurements are obtained in less than one seconds in each patient.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Corneal eye temperature both with and without silicone oil is measured using with noncontact infrared thermometer on the study visit
2. Body temperature is measured using a noncontact infrared thermometer on the study visit
Secondary outcome measures
No secondary outcome measures.
Overall trial start date
20/11/2015
Overall trial end date
01/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Require a pars plana vitrectomy and intraocular silicone oil tamponade
2. Aged between 36-88
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
38 Male / 22 Female
Participant exclusion criteria
1. Active ocular or periocular infection
2. Systemic infective illnesses
Recruitment start date
01/12/2015
Recruitment end date
30/05/2016
Locations
Countries of recruitment
Turkey
Trial participating centre
Istanbul Education and Research Hospital
Department of Ophthalmology
Kasap Ilyas Mah Org Abdurrahman Nafiz
Gurman Cad Fatih
Istanbul
34098
Turkey
Sponsor information
Organisation
Istanbul Research and Training Hospital
Sponsor details
Department of Ophthalmology
Kasap Ilyas Mah Org Abdurrahman Nafiz
Gurman Cad
Fatih
Istanbul
34098
Turkey
+90 505 238 2250
erkanunsal@gmail.com
Sponsor type
Hospital/treatment centre
Website
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
Not provided at time of registration.
IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/09/2017
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list