Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

Pterygium of Conjunctiva and Cornea Clinical Trial

Official title:

Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321201
• Other study ID #: PTERYGIUM1
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2022
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 31, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pterygium
• Pterygium of Conjunctiva and Cornea

Intervention

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.
• 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.

Locations

Country	Name	City	State
Croatia	University Hospital Split	Split

Sponsors (2)

Lead Sponsor	Collaborator
University of Split, School of Medicine	University Hospital of Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of pterygium	Any re-growth of tissue from the area of excision across the limbus onto the cornea.	180 days
Secondary	Surgical time	Surgical time: total operational time required for completion of the operation (measured in minutes)	During the surgery
Secondary	Complication rate	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, ?brosis, retraction and other indications that required special treatment	7, 30 and 180 days
Secondary	Pterygium-induced astigmatism	Measured as described by Hsu 2014	7, 30 and 180 days
Secondary	Ocular surface condition	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
Secondary	Postoperative discomfort, tearing, pain and foreign body sensation	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
Secondary	Pain	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
Secondary	Economic Analysis	Cost of each intervention	180 days
Secondary	Flap time	Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)	During the surgery