Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

November 1, 2022 updated by: Livia Puljak, University of Split, School of Medicine
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cauterization
Procedure: Cauterization
To ensure the stability of the graft during cuttings, four sealing wraps will be installed, which will be removed after cauterisation is completed. Autograft and conjunctiva will be approximated by surgical forceps and will be cauterized using a bipolar cutter (Erbe ICC 50) with a force 1-3 / 20. Forceps will be released slowly to prevent elevation of the graft. The same procedure will be performed 10 times until graft is well firmed. Graft stability will be checked up with a sponge and additional cauterization will be preformed if needed.
ACTIVE_COMPARATOR: Fibrin glue
Procedure: Fibrin glue
Fiber adhesive (Tissel 1 mL kit4-iu) will be prepared according to manufacturer's instructions. Preparation time will be approximately 10-15 min per kit. Once mixed the fibrin glue is usable up to 4 h. For the purpose of the study preparation of the fibrin glue will be performed by a nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of pterygium
Time Frame: 180 days
Any re-growth of tissue from the area of excision across the limbus onto the cornea.
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical time
Time Frame: During the surgery
Surgical time: total operational time required for completion of the operation (measured in minutes)
During the surgery
Complication rate
Time Frame: 7, 30 and 180 days
Complication rate will be analyzed as the occurrence of at least one of the following major complications such as dehiscence, displacement or loss of the autograft, infection, haemorrhage, oedema, fibrosis, retraction and other indications that required special treatment
7, 30 and 180 days
Pterygium-induced astigmatism
Time Frame: 7, 30 and 180 days
Measured as described by Hsu 2014
7, 30 and 180 days
Ocular surface condition
Time Frame: 7, 30 and 180 days
The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.
7, 30 and 180 days
Postoperative discomfort, tearing, pain and foreign body sensation
Time Frame: 7, 30 and 180 days
Using modified scale from Lim Bon Siong et al: (0) none, no pain, (1) very mild, (2) mild, pain causing some discomfort, (3) moderate, pain that partially interferes with usual activity or sleep, (4) sever, pain that completely interferes with usual activity or sleep.
7, 30 and 180 days
Pain
Time Frame: 7, 30 and 180 days
Numerical rating scale (NRS) ranging from 0 to 10, where 0 = No pain and 10 = Pain as intense as you can imagine.
7, 30 and 180 days
Economic Analysis
Time Frame: 180 days
Cost of each intervention
180 days
Flap time
Time Frame: During the surgery
Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)
During the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Collaborators

University Hospital of Split

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 8, 2018

Primary Completion (ANTICIPATED)

May 1, 2025

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (ACTUAL)

October 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTERYGIUM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data will be made available to other researchers on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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