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Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

Primary Purpose

Pterygium of Conjunctiva and Cornea

Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Cauterization
Fibrin glue
Sponsored by
University of Split, School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium of Conjunctiva and Cornea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University Hospital SplitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cauterization

Fibrin glue

Arm Description

Outcomes

Primary Outcome Measures

Recurrence of pterygium
Any re-growth of tissue from the area of excision across the limbus onto the cornea.

Secondary Outcome Measures

Surgical time
Surgical time: total operational time required for completion of the operation (measured in minutes)
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, fibrosis, retraction and other indications that required special treatment
Pterygium-induced astigmatism
Measured as described by Hsu 2014
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.
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.
Pain
Numerical rating scale (NRS) ranging from 0 to 10, where 0 = No pain and 10 = Pain as intense as you can imagine.
Economic Analysis
Cost of each intervention
Flap time
Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)

Full Information

First Posted
October 16, 2017
Last Updated
November 1, 2022
Sponsor
University of Split, School of Medicine
Collaborators
University Hospital of Split
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1. Study Identification

Unique Protocol Identification Number
NCT03321201
Brief Title
Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
Official Title
Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Split, School of Medicine
Collaborators
University Hospital of Split

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium of Conjunctiva and Cornea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Surgeons will not be blinded. All the other investigators, as well as study participants, outcome assessors and author that will analyze the data will be blinded.
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cauterization
Arm Type
Experimental
Arm Title
Fibrin glue
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Cauterization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fibrin glue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of pterygium
Description
Any re-growth of tissue from the area of excision across the limbus onto the cornea.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Surgical time
Description
Surgical time: total operational time required for completion of the operation (measured in minutes)
Time Frame
During the surgery
Title
Complication rate
Description
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
Time Frame
7, 30 and 180 days
Title
Pterygium-induced astigmatism
Description
Measured as described by Hsu 2014
Time Frame
7, 30 and 180 days
Title
Ocular surface condition
Description
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.
Time Frame
7, 30 and 180 days
Title
Postoperative discomfort, tearing, pain and foreign body sensation
Description
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.
Time Frame
7, 30 and 180 days
Title
Pain
Description
Numerical rating scale (NRS) ranging from 0 to 10, where 0 = No pain and 10 = Pain as intense as you can imagine.
Time Frame
7, 30 and 180 days
Title
Economic Analysis
Description
Cost of each intervention
Time Frame
180 days
Title
Flap time
Description
Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)
Time Frame
During the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University Hospital Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mladen Lesin, MD, PhD
Phone
0038521556111
Email
mladen.lesin@gmail.com
Phone
0038521556111
Email
mladen.lesin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual participant data will be made available to other researchers on request.
Citations:
PubMed Identifier
29950464
Citation
Lesin M, Paradzik M, Marin Lovric J, Olujic I, Ljubic Z, Vucinovic A, Bucan K, Puljak L. Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial. BMJ Open. 2018 Jun 27;8(6):e020714. doi: 10.1136/bmjopen-2017-020714.
Results Reference
derived

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Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

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