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

December 23, 2015 updated by: segev fani, Meir Medical Center

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

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

Study Overview

Status

Unknown

Conditions

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

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Kfar saba, Israel
        • Meir Medical Centre
      • Tel aviv, Israel
        • Sackler School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pterygium surgery: Head and body.
Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
Pterygium excision with application of mitomycin C
Two different procedures- excision of the head and the body and excision of the head only
Active Comparator: Pterygium surgery: Body.
Application of Mitomycin C 0.02% after excision of the body only of the pterygium.
Pterygium excision with application of mitomycin C
Two different procedures- excision of the head and the body and excision of the head only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial cell count
Time Frame: 3 months after surgery
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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