The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Meir Medical Center
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Endothelial cell count
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Pterygium surgery: Head and body.
Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
Intervention: Mitomycin C 0.02% (Drug)
Pterygium surgery: Head and body.
Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium.
Intervention: Pterygium surgery (Procedure)
Pterygium surgery: Body.
Application of Mitomycin C 0.02% after excision of the body only of the pterygium.
Intervention: Mitomycin C 0.02% (Drug)
Pterygium surgery: Body.
Application of Mitomycin C 0.02% after excision of the body only of the pterygium.
Intervention: Pterygium surgery (Procedure)
Outcomes
Primary Outcomes
Endothelial cell count
Time Frame: 3 months after surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
segev fani
Department of Ophthalmology, Meir medical centre, Kfar saba, Isreal
Meir Medical Center