Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

Not Applicable

Recruiting

• Conditions: Pterygium of Conjunctiva and Cornea
• Interventions: Procedure: Cauterization; Procedure: Fibrin glue

• Registration Number: NCT03321201
• Lead Sponsor: University of Split, School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Study Start: 2018-05-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02
• Primary Completion: 2025-05-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cauterization	Cauterization	-
Fibrin glue	Fibrin glue	-

Primary Outcome Measures

Name	Time	Method
Recurrence of pterygium	180 days	Any re-growth of tissue from the area of excision across the limbus onto the cornea.

Secondary Outcome Measures

Name	Time	Method
Pterygium-induced astigmatism	7, 30 and 180 days	Measured as described by Hsu 2014
Ocular surface condition	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.
Pain	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.
Complication rate	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
Postoperative discomfort, tearing, pain and foreign body sensation	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.
Surgical time	During the surgery	Surgical time: total operational time required for completion of the operation (measured in minutes)
Economic Analysis	180 days	Cost of each intervention
Flap time	During the surgery	Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)

Trial Locations

Locations (1)

University Hospital Split; 🇭🇷 Split, Croatia