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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02641132
Other study ID # 0091-13-MMC
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received December 23, 2015
Last updated December 23, 2015
Start date September 2015
Est. completion date December 2016

Study information

Verified date August 2015
Source Meir Medical Center
Contact Fani Segev, MD
Phone +792526995044
Email fsegev@netvision.net.il
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Interventional

Clinical Trial Summary

To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 62
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Mitomycin C 0.02%
Pterygium excision with application of mitomycin C
Procedure:
Pterygium surgery
Two different procedures- excision of the head and the body and excision of the head only

Locations

Country Name City State
Israel Meir medical centre Kfar saba
Israel Sackler school of medicine Tel aviv

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Endothelial cell count 3 months after surgery No
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