Clinical Trial: Outpatient Performed Pterygium Surgery Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Outpatient Performed Pterygium Surgery Study

Brief Summary: This is a randomized controlled trial of postoperative bevacizumab or 5-fluorouracil subconjunctival injections vs placebo for the recurrence of pterygia after excision using conjunctival autograft.

Detailed Summary:

Patients will be randomized at enrollment to one of three arms: 5-Fluorouracil (5-FU) 5mg/0.1mL, bevacizumab 2.5mg/0.1mL, or placebo. The placebo will be sterile, preservative-free injectable 0.9% normal saline. All patients will undergo pterygium excision surgery in the minor procedure room using a standardized surgical technique with conjunctival autograft. All patients will have a standardized postoperative drop protocol of neomycin/polymyxin/dexamethasone ointment four times daily for 2 weeks and fluorometholone drops 4 times daily for 2 weeks, three times daily for 2 weeks, twice daily for 2 weeks, once daily for 2 weeks then stopping.

At the 1-month and 2-month postoperative visits, patients will receive a subconjunctival injection based on their randomization assignment (5-FU, bevacizumab or placebo) in the area of the excised pterygium at least 1 mm posterior to the limbus. The total injected volume will be 0.1mL for all adjuvants.

The primary outcome will pterygium recurrence at 3 months, defined as evidence of at least 1 mm of fibrovascular growth onto the cornea. After the 3 month visit, patients who are determined to have a recurrence will be unmasked, and can received monthly 5-FU or bevacizumab injections at the discretion of the treating physician. Each of these visits will be treated as a study visit, and will be documented.

All patients will have study visits at the 6 and 12 month mark. If at any point any patient develops evidence of progression of recurrence, they may undergo further monthly 5-FU or bevacizumab injections at the discretion of the treating physician.


Sponsor: University of California, San Francisco

Current Primary Outcome: Recurrence [ Time Frame: 3 months ]

Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recurrence [ Time Frame: 6 months ]
    Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.
  • Recurrence [ Time Frame: 12 months ]
    Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: January 27, 2017
Date Started: May 1, 2017
Date Completion: May 1, 2020
Last Updated: January 27, 2017
Last Verified: January 2017