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

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ClinicalTrials.gov Identifier: NCT02641132
Recruitment Status : Unknown
Verified August 2015 by segev fani, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 29, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
segev fani, Meir Medical Center

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

Condition or disease Intervention/treatment Phase
Pterygium Drug: Mitomycin C 0.02% Procedure: Pterygium surgery Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.
Study Start Date : September 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.
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

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%
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




Primary Outcome Measures :
  1. Endothelial cell count [ Time Frame: 3 months after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641132


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

Locations
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Israel
Meir medical centre
Kfar saba, Israel
Sackler school of medicine
Tel aviv, Israel
Sponsors and Collaborators
Meir Medical Center

Publications:
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Responsible Party: segev fani, Department of Ophthalmology, Meir medical centre, Kfar saba, Isreal, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02641132     History of Changes
Other Study ID Numbers: 0091-13-MMC
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Pterygium
Conjunctival Diseases
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors