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

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Pterygium

Treatments: Procedure: Pterygium surgery; Drug: Mitomycin C 0.02%

Study type: Interventional

Funder types: Other

Identifiers

NCT02641132

0091-13-MMC

Details and patient eligibility

About

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

Full 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

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Pterygium surgery: Head and body.

Experimental group

Description:

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

Treatment:

Procedure: Pterygium surgery

Drug: Mitomycin C 0.02%

Pterygium surgery: Body.

Active Comparator group

Description:

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

Treatment:

Procedure: Pterygium surgery

Drug: Mitomycin C 0.02%