Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

University of Split

Status: Enrolling

Conditions: Pterygium of Conjunctiva and Cornea

Treatments: Procedure: Cauterization; Procedure: Fibrin glue

Study type: Interventional

Funder types: Other

Identifiers

NCT03321201

PTERYGIUM1

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 2 patient groups

Cauterization

Experimental group

Treatment:

Procedure: Cauterization

Fibrin glue

Active Comparator group

Treatment:

Procedure: Fibrin glue