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Assessment of subconjunctival bevacizumab effect on the postoperative healing course and recurrence of excised primary pterygium in patients referring to ophthalmology clinics

Protocol summary

Summary
Purpose: assessment of subconjunctival bevacizumab effect on the postoperative healing course and recurrence of excised primary pterygium. Design: randomized, double blind, placebo controlled, unicentric. Population: cases were selected from the patients referring to the ophthalmology clinics affiliated to Shiraz University of Medical Sciences, wanting removal of pterygium. Exclusion criteria: glaucoma, any previous limbal or pterygium surgery, obvious reflux from puncta, untreated diabetics, autoimmune disease, pregnant patients, ocular infection. Study size:32, after selecting the patients, pre-op exam was done and if met the criteria of study, after taking informed consent, were randomized into 2 groups, using random number tables. The group one (G1) had pterygium excision and rotational conjunctival flap with a total of 7.5 mg adjunctive subconjunctival bevacizumab (5mg/0.2ml on the surgery day and 2.5 mg/0.1 ml on the 4th day after surgery). The group 2 (G2) received 0.2ml Balanced Salt Solution (BSS) at the end of the surgery. Postoperatively, patients were examined at 1st day, 1st week, and 1st month, 3rd month, 6th and 12th month. In each exams, corneal epithelial defect, conjunctival erythema, lacrimation, photophobia, refraction, intraocular pressure are evaluated. Primary outcome measure in 2 groups is recurrence of pterygium.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138805192326N1
Registration date: 2010-09-28, 1389/07/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-28, 1389/07/06
Registrant information
Name
Mohammad Banifatemi
Name of organization / entity
Department of ophthalmology, Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1620 5131
Email address
mbani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2009-08-15, 1388/05/24
Expected recruitment end date
2010-09-01, 1389/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of subconjunctival bevacizumab effect on the postoperative healing course and recurrence of excised primary pterygium in patients referring to ophthalmology clinics
Public title
Assessment of subconjunctival bevacizumab effect on the postoperative healing course and recurrence of excised pterygium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients with primary pterygium referring to the ophthalmology clinics, affiliated to Shiraz University of Medical Sciences, that want pterygium removal. Exclusion criteria: glaucoma, regurgitation from lacrimal punctum (any indication of nasolacrimal obstruction), patients that seems not coming for follow-up exams during study, not treated diabetic patients, autoimmune diseases, pregnant patients, patients with ocular surface diseases or infections, two headed pterygium, previous limbal surgery, previous pterygial surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz university of medical sciences ethics committee
Street address
7th floor,Shiraz university of medical sciences, Zand St.
City
Shiraz
Postal code
Approval date
1389-05-21, 769/01/-303
Ethics committee reference number
ct-89-1527

Health conditions studied

1

Description of health condition studied
pterygium
ICD-10 code
H18.4
ICD-10 code description
corneal degeneration

Primary outcomes

1

Description
recurrence of pterygium
Timepoint
1 month, 3 months, 6 months after operation
Method of measurement
Slit lamp examination and measuring the size of recurrent pterygial tissue on cornea

Secondary outcomes

1

Description
healing of the surgical wound
Timepoint
1 week,1 month
Method of measurement
observing erythema, subconjunctival hemorrhage, corneal epithelial defect, tearing, photophobia of the patients

Intervention groups

1

Description
Intervention in cases: after excision of pterygium and rotational conjunctival flap,5 mg (0.2ml) of bevacizumab injected subconjunctivally in inferior fornix, and in the first post operative week additional 2.5mg of bevacizumab again injected in subconjunctival area in inferior fornix.
Category
Treatment - Drugs

2

Description
Intervention in controls: after excision of pterygium and rotational conjunctival flap, 0.2 ml of balanced salt solution, injected subconjunctivally in inferior fornix.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Poostchi eye clinic
Full name of responsible person
Street address
City
Shiraz

2

Recruitment center
Name of recruitment center
Motahhari eye clinic
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellery of Research Affairs of Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Dabbaghmanesh
Street address
7th floor, central building of Shiraz university of medical sciences, Zand Ave.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery of Research Affairs of Shiraz University of Medical Sciences
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
Shiraz university of medical sciences
Full name of responsible person
Mohammad Banifatemi
Position
Ophthalmology resident
Other areas of specialty/work
Street address
Department of ophthalmology, Khalili hospital, Khalili street
City
Shiraz
Postal code
Phone
+98 71 1647 1479
Fax
Email
mbanifatemi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Mohammad Banifatemi
Position
Resident of ophthalmology
Other areas of specialty/work
Street address
Department of ophthalmology, Khalili hospital, Khalili St.
City
Shiraz
Postal code
Phone
+98 71 1647 1479
Fax
Email
mbanifatemi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Mohammad Banifatemi
Position
Ophthalmology resident
Other areas of specialty/work
Street address
Department of ophthalmology, Khalili hospital, Khalili St.
City
Shiraz
Postal code
Phone
Fax
Email
mbanifatemi@gmail.com
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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