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Safety and efficacy of fibrin glue prepared from umbilical cord blood for attaching Conjunctival graft after pterygium excision

Protocol summary

Summary
Aim: The purpose of this study is to compare the fibrin glue prepared from Umbilical Cord Blood (UCB) Royan Institute, Tehran, Iran with a standard glue in pterygium excision surgery. Design: Randomized Clinical Trial Setting: Baqiyatallah Hospital, Ophthalmology Department, Tehran, Iran Major inclusion criteria: Patients who are suffering from pterygium associated with reduced visual acuity due to the proximity of pterygium to the visual axis; irregular astigmatism; and considerable ocular discomforts which are not responsive to the standard cares. Exclusion criteria: those who are suspected to ocular surface malignancies and/or keratoconjunctivitis; recurrent pterygium; systemic diseases (eg. diabetes, hypertension). Intervention: in the case group following pterygium excision surgery, conjunctival graft will be attached by umbilical cord blood fibrin glue, while in the control group, attachment will be accomplished by standard fibrin glue. Outcome measures: Complete loss of graft, partial graft dehiscence, graft hyperemia, subconjunctival hemorrhage, recurrence rate, post-operative pain and other ocular surface side effects.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021132503N1
Registration date: 2017-06-26, 1396/04/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Hossein Aghamollaei
Name of organization / entity
Baqiyatallah University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 2260
Email address
abrcl@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-03-28, 1396/01/08
Expected recruitment end date
2017-08-31, 1396/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of fibrin glue prepared from umbilical cord blood for attaching Conjunctival graft after pterygium excision
Public title
Safety and efficacy of fibrin glue prepared from umbilical cord blood in pterygium excision
Purpose
Treatment
Inclusion/Exclusion criteria
Patients who are suffering from pterygium associated with reduced visual acuity due to the proximity of pterygium to the visual axis, irregular astigmatism, and considerable ocular discomforts which are not responsive to the standard cares will be included in this study, whereas those who are suspected to ocular surface malignancies and/or keratoconjunctivitis, recurrent pterygium, and other general diseases (eg. Diabetes, hypertension) will be excluded.
Age
From 20 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be attained by using of random number tables.

Secondary Ids

1

Registry name
None
Secondary trial Id
None
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical sciences
Street address
Baqiyatallah University of Medical sciences
City
Tehran
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
IR.BMSU.REC.1392.82

Health conditions studied

1

Description of health condition studied
Pterygium
ICD-10 code
H11.0
ICD-10 code description
Conjunctival degenerations and deposits

Primary outcomes

1

Description
Subconjunctival hemorrhage
Timepoint
1,3 and 5 day and 1 and 3 months after surgery
Method of measurement
Mild:less than 1/3of graft, Moderate: from 1/3 to 2/3 of graft and sever: more than 2/3 of graft.

2

Description
Hyperemia
Timepoint
1,3 and 5 day and 1 and 3 months after surgery.
Method of measurement
Grade 0 – Absent (in case of normal vessels), Grade I – Mild (low vascular hyperemia), Grade II – Moderate (disseminated hyperemia), and Grade III – severe (hyperemia with disseminated vascular dilatation

3

Description
complete loss of graft
Timepoint
1,3 and 5 day and 1 and 3 months after surgery.
Method of measurement
observation

4

Description
partial graft dehiscence
Timepoint
1,3 and 5 day and 1 and 3 months after surgery.
Method of measurement
observation

5

Description
Recurrence rate
Timepoint
1 and 3 month after surgery
Method of measurement
observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The UCB-fibrin glue will be formulated in Royan Institute, Tehran, Iran. This is a prepared drop from the umbilical cord blood plasma of healthy mothers under sterile condition. In operation room, two drops of UCB-thrombin and one drop of UCB-Fibrinogen will be mixed and the resulting mixture will be put beyond the graft on its posterior position in a way that its limbus will be directed towards the limbus of the lesion
Category
Treatment - Surgery

2

Description
Control group: In control group, by using standard fibrin glue (Beriplast P, Germany), under company protocol, two drops of thrombin and one drop of fibrinogen will be used under the posterior surface of the graft in a way that its limbus will be directed towards the limbus of the lesion.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
investigator
Full name of responsible person
investigator
Street address
Baqiyatallah Hospital, Mollasadra street
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Royan Institute for Stem Cell Biology and Technology
Full name of responsible person
Marzieh Ebrahimi
Position
associate Profossor
Other areas of specialty/work
Street address
Royan Institute for Stem Cell Biology and Technology, , Hafez street, Hemmat highway
City
Tehran
Postal code
Phone
+98 989123448359
Fax
Email
marzieh.ebrahimi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah university of Medical Sciences
Full name of responsible person
Khosrow Jadidi
Position
associate Profossor
Other areas of specialty/work
Street address
Department of Ophthalmology, Baqiyatallah university of Medical Sciences, Molasadra street
City
tehran
Postal code
Phone
+98 21 8248 2260
Fax
Email
Kh.jadidi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Applied Biotechnology research Center, Baqiyatallah University of Medical sciences
Full name of responsible person
Hossein Aghamollaei
Position
Ph.D
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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