Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.

Pterygium Clinical Trial

— PHB-MMC1  

Official title:

The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02641132
• Other study ID #: 0091-13-MMC
• 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

• Pterygium

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