- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02641132
Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count. (PHB-MMC1)
December 23, 2015 updated by: segev fani, Meir Medical Center
The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.
To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
62
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fani Segev, MD
- Phone Number: +792526995044
- Email: fsegev@netvision.net.il
Study Contact Backup
- Name: Leena Asalee, MD
- Phone Number: +972543031396
- Email: leenaasalee@yahoo.com
Study Locations
-
-
-
Kfar saba, Israel
- Meir Medical Centre
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Tel aviv, Israel
- Sackler School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pterygium surgery: Head and body.
Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
|
Pterygium excision with application of mitomycin C
Two different procedures- excision of the head and the body and excision of the head only
|
Active Comparator: Pterygium surgery: Body.
Application of Mitomycin C 0.02% after excision of the body only of the pterygium.
|
Pterygium excision with application of mitomycin C
Two different procedures- excision of the head and the body and excision of the head only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelial cell count
Time Frame: 3 months after surgery
|
3 months after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
December 23, 2015
First Submitted That Met QC Criteria
December 23, 2015
First Posted (Estimate)
December 29, 2015
Study Record Updates
Last Update Posted (Estimate)
December 29, 2015
Last Update Submitted That Met QC Criteria
December 23, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0091-13-MMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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