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
Temperature effect of silicone oil at the anterior segment
The aim of this study is to measure the temperature difference between eyes with and without silicone oil tamponade.
Ethical Review Board of Istanbul Education and Research Hospital, 20/11/2015, ref: 2015-728
Observational single-centre cross-sectional study
Primary study design
Secondary study design
Cross sectional study
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Pars plana vitrectomy, intraocular silicone oil tamponade
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.
Primary outcome measures
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
Overall trial end date
Participant inclusion criteria
1. Require a pars plana vitrectomy and intraocular silicone oil tamponade
2. Aged between 36-88
Target number of participants
38 Male / 22 Female
Participant exclusion criteria
1. Active ocular or periocular infection
2. Systemic infective illnesses
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Istanbul Education and Research Hospital
Department of Ophthalmology Kasap Ilyas Mah Org Abdurrahman Nafiz Gurman Cad Fatih
Istanbul Research and Training Hospital
Department of Ophthalmology
Kasap Ilyas Mah Org Abdurrahman Nafiz
+90 505 238 2250
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
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
Participant level data
To be made available at a later date
Results - basic reporting