Back to resultsPterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count. (PHB-MMC1)
Primary Purpose
Pterygium
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Mitomycin C 0.02%
Pterygium surgery
Sponsored by
About this trial
This is an interventional prevention trial for Pterygium
Eligibility Criteria
Inclusion Criteria:
- Males/females >18 Years old
- Pterygium with indication to operate
- Subjects that are able to sign an informed consent
Exclusion Criteria:
- Recurrent Pterygium/suspected tumor lesion
- Patients with endothelial cell diseases
- Patients after anterior segment surgery
- Patients with low compliance
- Patients without judgment ability
- Pregnancy
- Patients participated in another survey
Sites / Locations
- Meir medical centre
- Sackler school of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pterygium surgery: Head and body.
Pterygium surgery: Body.
Arm Description
Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
Application of Mitomycin C 0.02% after excision of the body only of the pterygium.
Outcomes
Primary Outcome Measures
Endothelial cell count
Secondary Outcome Measures
Full Information
NCT ID
NCT02641132
First Posted
December 23, 2015
Last Updated
December 23, 2015
Sponsor
Meir Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02641132
Brief Title
Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.
Acronym
PHB-MMC1
Official Title
The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%
Detailed Description
To evaluate the change in endothelial cell count in patients after pterygium surgery with mitomycin C (MMC) 0.02% for 2 minutes in 2 groups.
The control group: application of MMC after excision of the body of the pterygium without the head
The study group: application of MMC after excision of the body and the head of the pterygium
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pterygium surgery: Head and body.
Arm Type
Experimental
Arm Description
Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
Arm Title
Pterygium surgery: Body.
Arm Type
Active Comparator
Arm Description
Application of Mitomycin C 0.02% after excision of the body only of the pterygium.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C 0.02%
Intervention Description
Pterygium excision with application of mitomycin C
Intervention Type
Procedure
Intervention Name(s)
Pterygium surgery
Intervention Description
Two different procedures- excision of the head and the body and excision of the head only
Primary Outcome Measure Information:
Title
Endothelial cell count
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males/females >18 Years old
Pterygium with indication to operate
Subjects that are able to sign an informed consent
Exclusion Criteria:
Recurrent Pterygium/suspected tumor lesion
Patients with endothelial cell diseases
Patients after anterior segment surgery
Patients with low compliance
Patients without judgment ability
Pregnancy
Patients participated in another survey
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fani Segev, MD
Phone
+792526995044
Email
fsegev@netvision.net.il
First Name & Middle Initial & Last Name or Official Title & Degree
Leena Asalee, MD
Phone
+972543031396
Email
leenaasalee@yahoo.com
Facility Information:
Facility Name
Meir medical centre
City
Kfar saba
Country
Israel
Facility Name
Sackler school of medicine
City
Tel aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
18520505
Citation
Avisar R, Avisar I, Bahar I, Weinberger D. Effect of mitomycin C in pterygium surgery on corneal endothelium. Cornea. 2008 Jun;27(5):559-61. doi: 10.1097/ICO.0b013e318165b158.
Results Reference
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PubMed Identifier
18992871
Citation
Bahar I, Kaiserman I, Lange AP, Slomovic A, Levinger E, Sansanayudh W, Slomovic AR. The effect of mitomycin C on corneal endothelium in pterygium surgery. Am J Ophthalmol. 2009 Mar;147(3):447-452.e1. doi: 10.1016/j.ajo.2008.08.035. Epub 2008 Nov 7.
Results Reference
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PubMed Identifier
19654528
Citation
Avisar R, Apel I, Avisar I, Weinberger D. Endothelial cell loss during pterygium surgery: importance of timing of mitomycin C application. Cornea. 2009 Sep;28(8):879-81. doi: 10.1097/ICO.0b013e3181a3900c.
Results Reference
background
PubMed Identifier
21236405
Citation
Kheirkhah A, Izadi A, Kiarudi MY, Nazari R, Hashemian H, Behrouz MJ. Effects of mitomycin C on corneal endothelial cell counts in pterygium surgery: role of application location. Am J Ophthalmol. 2011 Mar;151(3):488-93. doi: 10.1016/j.ajo.2010.09.014. Epub 2011 Jan 13.
Results Reference
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Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.
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