Condition category
Eye Diseases
Date applied
19/10/2018
Date assigned
19/11/2018
Last edited
23/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The retina is the thin layer at the back of the eye that contains the light-sensing cells. Retinal detachment is when this layer separates from the layer behind that contains blood vessels and other cells that support the survival of the light-sensing cells. Retinal detachment must be treated quickly to prevent vision loss. It is commonly managed by a vitrectomy procedure (removing some of the liquid in the eyeball) with the injection of silicone oil to hold the retina in place while it reattaches to the underlaying layer, but the oil may affect retinal function. Therefore removing the oil after the retina has healed might result in improved vision. This study aims to investigate whether the sensitivity of the retina to light is affected by silicone oil by measuring sensitivity before and after silicone oil removal.

Who can participate?
Participants included any patient who underwent a vitrectomy (retinal surgery) for retinal detachment using a silicone oil tamponade (a heavy oil used to maintain the retina in its place). Participants eyes were examined before and after silicone oil removal.

What does the study involve?
The study involves a non-invasive investigation called microperimetry to assess retinal sensitivity. It also includes tests of vision and pressure in the eye.

What are the possible benefits and risks of participating?
Participants might benefit from more explanation of their surgery and more investigation if their sight has worsened. All the tests are non-invasive, so there was no additional risk from participating in the study.

Where is the study run from?
Cairo University Hospital

When is the study starting and how long is it expected to run for?
August 2016 to May 2017

Who is funding the study?
The investigators funded the study.

Who is the main contact?
Dr Hebatalla Makled, Lecturer of Ophthalmology, Kasr Al-Ainy teaching hospital.

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Dr Hebatalla Makled

ORCID ID

http://orcid.org/0000-0002-3834-2538

Contact details

Ophthalmology department
Kasr Al-Ainy hospital
Faculty of Medicine- Cairo university
Cairo
11562
Egypt

Type

Scientific

Additional contact

Dr Maha Youssef

ORCID ID

http://orcid.org/0000-0003-1637-056X

Contact details

Ophthalmology department
Kasr Al-Ainy hospital
Faculty of Medicine- Cairo university
Cairo
11562
Egypt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Retinal sensitivity before and after silicone oil removal using microperimetry

Acronym

Study hypothesis

To investigate the effect of silicone oil on the retina through assessment of retinal sensitivity, using microperimetry, before and after silicone removal.

Ethics approval

Cairo University Ophthalmology department ethics board, 17/10/2016. No reference number.

Study design

Observational prospective comparative study

Primary study design

Observational

Secondary study design

Prospective comparative

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Rhegmatogenous retinal detachment

Intervention

All participants received microperimetry examination one day prior to and one month after silicone oil removal. Silicone oil removal was performed using an infusion-extraction technique with two standard sclerotomies.
During microperimetry, participants were examined in a dark room for 15 minutes with occlusion of the non-tested eye. They were asked to fixate on a central target. A customised pattern centered on the central 11º was used, after auto-correction of patient's refractive error by the machine, with the following features: Goldmann III stimulus size, 200 millisecond stimulus duration, a 1500 millisecond interval between stimuli and a 4 – 2 strategy on a 1.27 cd/m² background.
Retinal sensitivity was tested at 28 points: 4 stimuli at 2.3º, 12 stimuli at 6.6º and 12 stimuli at 11º. The stimulus level ranged between 0 dB and 20 dB. The total retinal sensitivity and sensitivity of each layer (inner, middle and outer) were assessed.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Retinal sensitivity, assessed using microperimetry one day before silicone oil removal and one month after silicone oil removal.

Secondary outcome measures

The following are assessed one day prior to silicone oil removal and 1 day, 1 week, 2 weeks and 1 month after surgery:
1. Best corrected visual acuity (BCVA), assessed using a Snellen chart and converted into logMAR using statistical analysis
2. Intraocular pressure, assessed using the Goldmann applanation tonometer

Overall trial start date

01/08/2016

Overall trial end date

31/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Macula off rhegmatogenous retinal detachment with any grade of proliferative vitreoretinopathy (PVR)
2. Pars plana vitrectomy (PPV) with silicone oil 5000 as a tamponading agent
3. Aged 18 years or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

22 (10 patients in group A, 12 patients in group B)

Participant exclusion criteria

1. Undergoing vitrectomies for proliferative diabetic retinopathy
2. Recurrent retinal detachments,
3. Macular holes,
4. Chorioretinal degenerations involving the macula
5. Developed the following complications following oil removal:
5.1. Visually significant cataracts
5.2. Secondary glaucoma with intraocular pressure (IOP) exceeding 26 mmHg
5.3. Silicone oil emulsification
5.4. Recurrent detachment
5.5. Hypotony

Recruitment start date

01/11/2016

Recruitment end date

30/04/2017

Locations

Countries of recruitment

Egypt

Trial participating centre

Kasr Al-Ainy teaching hospital
Faculty of Medicine- Cairo University
Cairo
11562
Egypt

Sponsor information

Organisation

Ophthalmology department, Kasr Al-Ainy hospital, Cairo University

Sponsor details

Faculty of medicine
Kasr Al-Ainy street
Cairo
11562
Egypt

Sponsor type

University/education

Website

www.medicine.cu.edu.eg

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish our results in November 2018

IPD sharing statement:
All the data used and/or analysed during the current study are available and can be presented by the corresponding author upon a reasonable request from Hebatalla Makled, MD (Lecturer of Ophthalmology, Kasr Al-Ainy Teaching Hospital, Faculty of Medicine, Cairo University) (dr.h.makled@hotmail.com)

Intention to publish date

19/11/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2018: Internal review.