ISRCTN ISRCTN69502156
DOI https://doi.org/10.1186/ISRCTN69502156
Secondary identifying numbers N/A
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 logoORCID ID 0000-0002-5811-1550
Phone +90 505 238 22 50
Email erkanunsal@gmail.com

Study information

Study designObservational single-centre cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet
Scientific titleTemperature effect of silicone oil at the anterior segment
Study objectivesThe 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) studiedPars plana vitrectomy, intraocular silicone oil tamponade
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures.
Overall study start date20/11/2015
Completion date01/09/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants38 Male / 22 Female
Key inclusion criteria1. Require a pars plana vitrectomy and intraocular silicone oil tamponade
2. Aged between 36-88
Key exclusion criteria1. Active ocular or periocular infection
2. Systemic infective illnesses
Date of first enrolment01/12/2015
Date of final enrolment30/05/2016

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

Sponsor information

Istanbul Research and Training Hospital
Hospital/treatment centre

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

Phone +90 505 238 2250
Email erkanunsal@gmail.com
ROR logo "ROR" https://ror.org/00nwc4v84

Funders

Funder type

Not defined

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/09/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planNot provided at time of registration.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

09/02/2017: Internal review.