Condition category
Eye Diseases
Date applied
19/01/2017
Date assigned
30/01/2017
Last edited
09/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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

20/11/2015

Overall trial end date

01/09/2016

Reason abandoned

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/02/2017: Internal review.