The comparison of endothelial cell changes, pterygium thickness and recurrence rate between preoperative subpterygeal injection of bevacizumab Vs mitomycin C
objectives: to compare endothelial cell changes, pterygium thickness and recurrence rate between preoperative subpterygeal injection of bevacizumab Vs mitomycin C
Design: Randomized clinical trial
setting: Patients with primary pterygium who come to Khatam Eye Hospital between May 2016 to November 2016 were divided to two groups .
Participants: Consecutive patients with priamry pterygium without history of previous pterygium surgery,pregnancy,glaucoma and autoimmune disease
intervention: 1 month preoperative subpterygeal injection of bevacizumab vs mitomycin C
main outcome measures: recurrence rate, endothelial cell changes, pterygium thickness
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042227525N1
Registration date:2016-07-02, 1395/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Ameneh Karimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 1401
Email address
karimia921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of endothelial cell changes, pterygium thickness and recurrence rate between preoperative subpterygeal injection of bevacizumab Vs mitomycin C
Public title
Preoperative subpterygeal injection of bevacizumab Vs mitomycin C for pterygium surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primary pterygium
Exclusion criteria;: Pregnancy ; history of pterygium surgery; glaucoma; trachoma ; autoimmune disease
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
.
Secondary trial Id
.
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Mashhad University of Medical Sciences
Street address
Qoreishi Building, Daneshgah St, Mashhad, Iran
City
Mashhad
Postal code
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
IR.MUMS.fm.REC.13940210
Health conditions studied
1
Description of health condition studied
Pterygium
ICD-10 code
H11.0
ICD-10 code description
Excl.psudopterygium(H11.8)
Primary outcomes
1
Description
Pterygium thickness
Timepoint
Preoperative subpterygeal njection and 1 month after injectin of mitomycin C and bevacizumab
Method of measurement
Anterior segment OCT
2
Description
Endothelial cell count
Timepoint
Preoperative subpterygeal injection and 1 ,3, 6 month after pterygium surgery
Method of measurement
Specular microscopy
Secondary outcomes
1
Description
Recurrence rate of pterygium
Timepoint
6 months after pterygium surgery
Method of measurement
Eye examination with Slit-lamp biomicroscope
Intervention groups
1
Description
Group a: 1month preoperative subpterygeal injection of 0.1 cc mitomycin C
Category
Treatment - Drugs
2
Description
Group b: ١ month preoperative subpterygeal injection of 0.1 cc bevacizumab
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Al-Anbia Eye Hospital
Full name of responsible person
Hamid Khakshoor, Professor of Ophthalmology ,Anterior Segment Fellowship