Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 164
- Locations
- 2
- Primary Endpoint
- Recurrence of pterygium
Study Overview
Brief Summary
Pterygium is a noncancerous growth of the conjunctival tissue over the cornea. It is a progressive disease that may lead to visual impairment in advanced stages, as well as restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. In this randomized controlled cauterization will be compared with fibrin glue for conjunctival autografting in primary pterygium surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Surgeons will not be blinded. All the other investigators, as well as study participants, outcome assessors and author that will analyze the data will be blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults (older than 18 years of age)
- •both sexes
- •primary nasal pterygia ˃4 mm, which tends to increase, including patients with reduced visual acuity, chronic inflammation, cosmetic reasons
- •if the patients had a bilateral pterygium, only one eye will be operated
Exclusion Criteria
- •connective tissue disease
- •prior eye surgery
- •chronic use of topical drugs (anti-glaucoma drugs)
Outcomes
Primary Outcomes
Recurrence of pterygium
Time Frame: 180 days
Any re-growth of tissue from the area of excision across the limbus onto the cornea.
Secondary Outcomes
- Pterygium-induced astigmatism(7, 30 and 180 days)
- Ocular surface condition(7, 30 and 180 days)
- Pain(7, 30 and 180 days)
- Complication rate(7, 30 and 180 days)
- Postoperative discomfort, tearing, pain and foreign body sensation(7, 30 and 180 days)
- Surgical time(During the surgery)
- Economic Analysis(180 days)
- Flap time(During the surgery)
Investigators
Livia Puljak
Associate Professor
University of Split, School of Medicine