NCT02641132

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 29, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

December 23, 2015

Last Update Submit

December 23, 2015

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

  • Endothelial cell count

    3 months after surgery

Study Arms (2)

Pterygium surgery: Head and body.

EXPERIMENTAL

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

Pterygium surgery: Body.

ACTIVE COMPARATOR

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

Drug: Mitomycin C 0.02%Procedure: Pterygium surgery

Interventions

Mitomycin C 0.02%DRUG

Pterygium excision with application of mitomycin C

Pterygium surgery: Body.Pterygium surgery: Head and body.
Pterygium surgeryPROCEDURE

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

Pterygium surgery: Body.Pterygium surgery: Head and body.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sackler school of medicine

Tel Aviv, Israel, Israel

Location

Meir medical centre

Kfar Saba, Israel

Location

Related Publications (4)

  • 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.

    PMID: 18520505BACKGROUND

  • 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.

    PMID: 18992871BACKGROUND

  • 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.

    PMID: 19654528BACKGROUND

  • 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.

    PMID: 21236405BACKGROUND

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Central Study Contacts

Fani Segev, MD

CONTACT

+792526995044fsegev@netvision.net.il

Leena Asalee, MD

CONTACT

+972543031396leenaasalee@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Ophthalmology, Meir medical centre, Kfar saba, Isreal

Study Record Dates

First Submitted

December 23, 2015

First Posted

December 29, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 29, 2015

Record last verified: 2015-08

Locations

IL(2)