Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.
NCT ID: NCT02641132
Last Updated: 2015-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
62 participants
INTERVENTIONAL
2015-09-30
2016-12-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Pterygium surgery: Head and body.
Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
Mitomycin C 0.02%
Pterygium excision with application of mitomycin C
Pterygium surgery
Two different procedures- excision of the head and the body and excision of the head only
Pterygium surgery: Body.
Application of Mitomycin C 0.02% after excision of the body only of the pterygium.
Mitomycin C 0.02%
Pterygium excision with application of mitomycin C
Pterygium surgery
Two different procedures- excision of the head and the body and excision of the head only
Interventions
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Mitomycin C 0.02%
Pterygium excision with application of mitomycin C
Pterygium surgery
Two different procedures- excision of the head and the body and excision of the head only
Eligibility Criteria
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Inclusion Criteria
* Pterygium with indication to operate
* Subjects that are able to sign an informed consent
Exclusion Criteria
* Patients with endothelial cell diseases
* Patients after anterior segment surgery
* Patients with low compliance
* Patients without judgment ability
* Pregnancy
* Patients participated in another survey
18 Years
ALL
Yes
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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segev fani
Department of Ophthalmology, Meir medical centre, Kfar saba, Isreal
Locations
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Sackler school of medicine
Tel Aviv, Israel, Israel
Meir medical centre
Kfar Saba, , Israel
Countries
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Central Contacts
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References
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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.
Other Identifiers
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0091-13-MMC
Identifier Type: -
Identifier Source: org_study_id