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

Phase 4

• Conditions: Pterygium
• Interventions: Drug: Mitomycin C 0.02%; Procedure: Pterygium surgery

• Registration Number: NCT02641132
• Lead Sponsor: Meir Medical Center

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-09
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-23
• Last Update Submitted: 2015-12-23
• Study First Posted: 2015-12-29
• Last Update Posted: 2015-12-29
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pterygium surgery: Head and body.	Mitomycin C 0.02%	Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
Pterygium surgery: Head and body.	Pterygium surgery	Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
Pterygium surgery: Body.	Pterygium surgery	Application of Mitomycin C 0.02% after excision of the body only of the pterygium.
Pterygium surgery: Body.	Mitomycin C 0.02%	Application of Mitomycin C 0.02% after excision of the body only of the pterygium.

Primary Outcome Measures

Name	Time	Method
Endothelial cell count	3 months after surgery

Trial Locations

Locations (2)

Meir medical centre; 🇮🇱 Kfar saba, Israel

Sackler school of medicine; 🇮🇱 Tel aviv, Israel