Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial

Abstract

IntroductionPterygium is a non-cancerous growth of the conjunctival tissue over the cornea that may lead to visual impairment in advanced stages, restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. It has been previously shown that fibrin glue may result in less recurrence and may take less time than sutures for fixing the conjunctival graft in place during pterygium surgery. However, fibrin glue is a biological material and it carries the risk of transmitting infectious agents from pooled and single-donor blood donors and anaphylaxis in susceptible individuals. Cauterisation is another surgical option, and it would be advantageous to know whether cauterisation may be superior surgical option compared with fibrin glue. This protocol describes the rationale and design of the randomised controlled trial (RCT) in which we will compare cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery.Methods and analysesThis will be a parallel group RCT comparing cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery. Computer-generated randomisation will be used, and allocation concealment will be conducted using sequentially numbered opaque sealed envelopes. Surgeons will not be blinded to the procedures, but participants, other investigators and outcome assessors will be blinded. Adult participants with primary pterygium operated in a tertiary hospital in Split, Croatia, will be included. Primary outcome will be recurrence of pterygium, defined as any regrowth of tissue from the area of excision across the limbus onto the cornea after 180 days.Ethics and disseminationThe trial was approved by the ethics review board of the University Hospital Split (500-03/17-01/68). Results will be disseminated at conferences and through peer-reviewed publications.Trial registration numberNCT03321201; Pre-results.

A Comparative Study of Conjunctival Autograft With Sutures Versus Autologous Serum in-Situ in Pterygium Surgery in a Tertiary Care Centre

“…This technique uses blood oozing from the surgical site. 13,5 In the present study, in Group 1, 8% of the patients were in the age group 21-30 years, 20% were in the age group 31-40 years, 34% were in the age group 41-50 years, 26% were in the age group 51-60 years and 12% were in the age group 61-70 years. In Group 2, 10% of the patients were in the age group 21-30 years, 30% were in the age group 31-40 years, 28% were in the age group 41-50 years, 22% were in the age group 51-60 years and 10% were in the age group 61-70 years.…”

How to minimize pterygium recurrence rates: clinical perspectives

“…A clinical trial has been recently presented in order to evaluate the feasibility of this method in comparison with fibrin glue. 55 …”

Comparing Adjuvant Beta Radiation, Mitomycin C, and Conjunctival Autograft in Primary Pterygium Treatment, a Three-year Follow-up Study

“…Pterygium surgery has gone through many developmental stages. The first operation was the bare sclera technique; the procedure had a high recurrence (24%-89%) [4,11]. The former led to the development of other surgical maneuvers that aimed to lower pterygium recurrence.…”

“…M. Ali reported a recurrence rate of 6.82% following B radiation in patients with pterygium [16]. We believe if excessive cauterization is done at the time of surgery, this will induce the pterygium's aggressive return later on [4].…”