The aim of the study was to evaluate pre-operative, intra-operative and post-operative factors which may influence visual gain after vitrectomy for non-clearing vitreous haemorrhage (VH) in patients with severe proliferative diabetic retinopathy (PDR).
Design
A single arm group, 172 eyes of 143 patients, non-randomised, single center.
Settings and conduct
The study was conducted at the Clinic of Ophthalmology, Emergency County Hospital, Cluj-Napoca, Romania. A single surgeon performed 3-port 23 gauge transconjunctival sutureless vitrectomy. Depending on the situation, aspiration of the VH, peeling or dissection of the tractional membranes was carried out. If needed, retinal endolaser (panretinal photocoagulation PRP or laser completion) was performed. Phacoemulsification with intraocular lens insertion and PPV were combined when the lens opacification prevented the visualization of the posterior segment. At the end of surgery, the vitreous cavity was left under Ballance Salt Solution (BSS), air or silicone oil 1000cSt. Some of the patients underwent a single injection of IVB, 3.8 days prior to PPV. After sterile preparation and draping, 1.25mg/0.05 ml Bevacizumab (Avastin, Genetech) were injected intravitreally in the operating theatre, under topical anaesthesia. Topical antibiotic (tobramycine) was started in the same day and was continued for 5 days post injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pars plana vitrectomy(PPV) for non-clearing diabetic VH for more than a month. Exclusion criteria: follow-op for less than 3 months.
Intervention groups
Intervention consisted in pars plana vitrectomy (removal of the vitreous body).
Main outcome variables
Postoperative best corrected visual acuity
Frequency of early onset and late onset postoperative hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200312046750N1
Registration date:2020-03-26, 1399/01/07
Registration timing:retrospective
Last update:2020-03-26, 1399/01/07
Update count:0
Registration date
2020-03-26, 1399/01/07
Registrant information
Name
Ioana Damian
Name of organization / entity
Iuliu Hatieganu University of Medicine and Pharmacy
Country
Romania
Phone
+40 359 807 824
Email address
ioana.damian@umfcluj.ro
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2018-01-01, 1396/10/11
Actual recruitment start date
2012-01-01, 1390/10/11
Actual recruitment end date
2018-01-01, 1396/10/11
Trial completion date
2018-01-01, 1396/10/11
Scientific title
Visual outcomes and prognostic factors following pars plana vitrectomy for vitreous haemorrhage in patients with diabetic retinopathy
Public title
Vitrectomy for diabetic vitreous hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non clearing vitreous hemorrhage for more than a month
Severe diabetic retinopathy
Treatment: pars plana vitrectomy
Single surgeon experience
Exclusion criteria:
Follow-up less than 3 months
Other macular diseases, advanced glaucoma
History of ocular trauma
History of pars plana vitrectomy for tractional retinal detachment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
More than 1 sample in each individual
Number of samples in each individual:
2
2 eyes/patient if both eyes have PDR
Actual sample size reached:
143
More than 1 sample in each individual
Actual sample size in each individual:
2
172 eyes of 141 patients
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the "Iuliu Hatieganu" University of Medicine and Pharmacy
Street address
No.8, Victor Babes
City
Cluj-Napoca
Postal code
400012
Approval date
2020-03-24, 1399/01/05
Ethics committee reference number
131
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy
ICD-10 code
E08.35
ICD-10 code description
Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy
Primary outcomes
1
Description
Postoperative best corrected visual acuity(BCVA)
Timepoint
3 months after pars plana vitrectomy
Method of measurement
Measurement of the visual acuity using Snellen chart
2
Description
Frequency of postoperative early and late vitreous hemorrhage
Timepoint
Early onset: < 4 weeks and late onset > 4 weeks
Method of measurement
Slit lamp and ophthalmoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention consisted in pars plana vitrectomy (removal of the vitreous body). If needed, retinal endolaser (panretinal photocoagulation PRP or laser completion) was performed. Phacoemulsification with intraocular lens insertion and PPV were combined when the lens opacification prevented the visualization of the posterior segment. At the end of surgery, the vitreous cavity was left under Ballance Salt Solution (BSS), air or silicone oil 1000cSt
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Ophthalmology, Emergency County Hospital
Full name of responsible person
Ioana Damian
Street address
No.3-5, Clinicilor street
City
Cluj-Napoca
Postal code
400006
Phone
+40 264 597 852
Email
ioana.damian@umfcluj.ro
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medicine and Pharmacy ,,Iuliu Hatieganu"
Full name of responsible person
Ioana Damian
Street address
No.8 Victor Babes
City
Cluj-Napoca
Postal code
400012
Phone
+40 264 597 256
Email
ioana.damian@umfcluj.ro
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medicine and Pharmacy ,,Iuliu Hatieganu"
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
,,Iuliu Hatieganu" University of Medicine and Pharmacy
Full name of responsible person
Ioana Damian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No.8 Victor Babes
City
Cluj-Napoca
Province
Cluj
Postal code
400012
Phone
+40 264 597 256
Email
ioana.damian@umfcluj.ro
Person responsible for scientific inquiries
Contact
Name of organization / entity
,,Iuliu Hatieganu" University of Medicine and Pharmacy
Full name of responsible person
Ioana Damian
Position
Assistant Proffesor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No.8 Victor Babes
City
Cluj-Napoca
Province
Cluj
Postal code
400012
Phone
+40 264 597 256
Email
ioana.damian@umfcluj.ro
Person responsible for updating data
Contact
Name of organization / entity
,,Iuliu Hatieganu" University of Medicine and Pharmacy
Full name of responsible person
Ioana Damian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
No.8 Victor Babes
City
Cluj-Napoca
Province
Cluj
Postal code
400012
Phone
+40 264 597 256
Email
ioana.damian@umfcluj.ro
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of the confidentiality of the information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available