Condition category
Eye Diseases
Date applied
15/07/2018
Date assigned
24/07/2018
Last edited
24/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Babies born prematurely have a very low birth weight. In Turkey, 25,000 very low weight babies are born annually, with around 1000 of them facing the risk of blindness (retinopathy of prematurity (ROP)).
The likelihood of these babies developing ROP is affected by the treatment and follow-up that they receive, along with any complications. We retrospectively reviewed the treatment, follow-up period and treatment complications of 302 premature, low birth weight babies who were examined for ROP at SBÜ Bursa YİEAH ROP between the dates of February 2016 to February 2017, to determine the effects of treatment and complications of ROP and demonstrate that complete rehabilitation can be achieved with strict follow-up and appropriate treatment.

Who can participate?
Premature babies, born between 6 and 35 weeks of gestation

What does the study involve?
There is no direct participation for infants involved in the study. Instead, this is a retrospective review of the treatment, follow-up period and treatment complications of participants.

What are the possible benefits and risks of taking part?
The possible benefit of taking part is that it may help prevent severe vision loss in future premature babies. There are no known risks to participants taking part in this study.

Where is the study run from?
SBU Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Turkey

When is the study starting and how long is it expected to run for?
1st July 2018 to 15th July 2018

Who is funding the study?
1. Social Security Institution (Turkey)
2. SBU Bursa Yüksek İhtisas Training and Research Hospital (Turkey)

Who is the main contact?
1. Müberra Akdoğan (mbrakdogan@yahoo.com)
2. Görkem Çevik (gorkemcevic@hotmail.com)

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Müberra Akdoğan

ORCID ID

http://orcid.org/0000-0003-4846-312X

Contact details

Mursel Mah. Egitim Cad. 16. sok. Sevilla Villaları G1 villa no.1
Bursa
16110
Turkey
05052408229
mbrakdogan@yahoo.com

Type

Scientific

Additional contact

Dr Sadık Görkem Çevik

ORCID ID

http://orcid.org/0000-0002-5653-5800

Contact details

SBU Bursa Yüksek İhtisas Training and Research Hospital
Mimar Sinan Mah. Emniyet Cad. Polis Okulu Karşısı Yıldırım
Bursa
16310
Turkey
+90 224 295 50 00
gorkemcevik@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7929783.v1

Study information

Scientific title

Diagnosis, treatment and complications of retinopathy of prematurity

Acronym

ROP

Study hypothesis

To determine the effects of diagnosis, treatment and complications of retinopathy of prematurity and demonstrate that complete rehabilitation can be achieved with strict follow-up and appropriate treatment of severe ROP

Ethics approval

SBU Bursa Higher Specialized Education Research Hospital, 01/07/2018, 31234050-514.10

Study design

Observational cross sectional retrospective review

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Retinopathy of prematurity

Intervention

Records were reviewed, using the International Classification of Retinopathy of Prematurity (ICROP) criteria to review diagnoses and the Early Treatment of Retinopathy of Prematurity (ETROP) study group criteria to review treatments.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

The following were measured from birth to the end of the follow-up period:
1. Total maturation of retinal vascularisation
2. IVB (intravitreal bevacizumab) dose
3. LPC (laser photocoagulation) treatment
4. Complications after treatment
5. Stage of ROP
6. Gender of infant
7. Follow-up duration (weeks)
8. Gestational week of birth
9. Incubation duration (days)

Secondary outcome measures

N/A

Overall trial start date

01/07/2018

Overall trial end date

15/07/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Preterm babies born between 6 and 35 weeks of gestation

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Various ROP stages were observed in 118; no ROP was observed in 184. Infants with and without ROP

Participant exclusion criteria

N/A

Recruitment start date

01/02/2016

Recruitment end date

01/02/2017

Locations

Countries of recruitment

Turkey

Trial participating centre

Department of Ophthalmology, University of Health Sciences (SBU) Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Turkey
SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi Mimarsinan Mahallesi, No:, Emniyet Cd. No:35, 16310 Yıldırım/Bursa
BURSA
16310
Turkey

Sponsor information

Organisation

Department of Ophthalmology, University of Health Sciences (SBU) Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Turkey

Sponsor details

Mimar Sinan Mah. Emniyet Cad. Polis Okulu Karşısı
Bursa
16340
Turkey
+90 224 295 50 00
mbrakdogan@yahoo.com

Sponsor type

Government

Website

bursaihtisas.saglik.gov.tr

Funders

Funder type

Not defined

Funder name

Absent

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
Retinal images (if available) and clinical follow-up information without the patient's identity information can be obtained from mbrakdogan@yahoo.com.

Intention to publish date

02/08/2018

Participant level data

Available on request

Basic results (scientific)

Serious loss of vision can be avoided in stage 2-3 and higher ROP if regular follow-ups and appropriate and timely treatment are performed. The success rate continues to improve because of collaboration among ophthalmologists, more treatment options, and appropriate and timely treatment

Publication list

2015 results in https://www.researchgate.net/publication/273324460_Relationship_between_mean_platelet_volume_and_retinopathy_of_prematurity

Publication citations

Additional files

Editorial Notes