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Status unknownNCT02641132PHB-MMC1Updated Dec 29, 2015

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

A Phase 4 interventional study of Mitomycin C 0.02% and Pterygium surgery in Pterygium, sponsored by Meir Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-29.

Sponsored by Meir Medical Center · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Pterygium

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03

In context

Pterygium

111 studies on the registry are indexed under Pterygium; 10 are open to participants now.

This study's planned enrollment of 62 is close to the median of 60 across 92 interventional studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males/females >18 Years old
  • Pterygium with indication to operate
  • Subjects that are able to sign an informed consent

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Pterygium surgery: Head and body.

    Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.

    Drug: Mitomycin C 0.02% · Procedure: Pterygium surgery

  • Active comparator
    Pterygium surgery: Body.

    Application of Mitomycin C 0.02% after excision of the body only of the pterygium.

    Drug: Mitomycin C 0.02% · Procedure: Pterygium surgery

Interventions

  • DrugMitomycin C 0.02%

    Pterygium excision with application of mitomycin C

  • ProcedurePterygium surgery

    Two different procedures- excision of the head and the body and excision of the head only

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What researchers measure

Primary outcomes

  1. Endothelial cell count

    Time frame: 3 months after surgery

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Study locations

2 sites
  • Meir medical centre
    Kfar saba, Israel
  • Sackler school of medicine
    Tel aviv, Israel
08

References and documents

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. PubMed 18520505 ↗
  • 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. PubMed 18992871 ↗
  • 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. PubMed 19654528 ↗
  • 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. PubMed 21236405 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02641132
Lead sponsor
Meir Medical Center
Responsible party
segev fani (Department of Ophthalmology, Meir medical centre, Kfar saba, Isreal, Meir Medical Center) — Principal investigator
First posted
Dec 29, 2015
Start date
Sep 2015
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Dec 29, 2015

Study contacts

Fani Segev, MD
Contact
fsegev@netvision.net.il
+792526995044
Leena Asalee, MD
Contact
leenaasalee@yahoo.com
+972543031396

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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