Does silicone oil change ocular temperature?

ISRCTN	ISRCTN69502156
DOI	https://doi.org/10.1186/ISRCTN69502156
Protocol serial number	N/A
Sponsor	Istanbul Research and Training Hospital
Funder	Investigator initiated and funded

Submission date: 19/01/2017
Registration date: 30/01/2017
Last edited: 09/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Erkan Unsal
Public

Istanbul Research and Training Hospital
Department of Ophthalmology
Kasap Ilyas Mah Org Abdurrahman Nafiz
Gurman Cad
Fatih
Istanbul
34098
Türkiye

ORCID ID	0000-0002-5811-1550
Phone	+90 505 238 22 50
Email	erkanunsal@gmail.com

Study information

Primary study design	Observational
Study design	Observational single-centre cross-sectional study
Secondary study design	Cross sectional study
Study type	Participant information sheet
Scientific title	Temperature effect of silicone oil at the anterior segment
Study objectives	The aim of this study is to measure the temperature difference between eyes with and without silicone oil tamponade.
Ethics approval(s)	Ethical Review Board of Istanbul Education and Research Hospital, 20/11/2015, ref: 2015-728
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures.
Completion date	01/09/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Require a pars plana vitrectomy and intraocular silicone oil tamponade 2. Aged between 36-88
Key exclusion criteria	1. Active ocular or periocular infection 2. Systemic infective illnesses
Date of first enrolment	01/12/2015
Date of final enrolment	30/05/2016

Locations

Countries of recruitment

Türkiye

Study participating centre

Istanbul Education and Research Hospital

Department of Ophthalmology
Kasap Ilyas Mah Org Abdurrahman Nafiz
Gurman Cad Fatih
Istanbul
34098
Türkiye

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/02/2017: Internal review.