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Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

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ClinicalTrials.gov Identifier: NCT03321201
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
University Hospital of Split
Information provided by (Responsible Party):
Livia Puljak, 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.

Condition or disease Intervention/treatment Phase
Pterygium of Conjunctiva and Cornea Procedure: Cauterization Procedure: Fibrin glue Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  1. Recurrence of pterygium [ Time Frame: 180 days ]
    Any re-growth of tissue from the area of excision across the limbus onto the cornea.


Secondary Outcome Measures :
  1. Surgical time [ Time Frame: During the surgery ]
    Surgical time: total operational time required for completion of the operation (measured in minutes)

  2. 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

  3. Pterygium-induced astigmatism [ Time Frame: 7, 30 and 180 days ]
    Measured as described by Hsu 2014

  4. 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.

  5. 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.

  6. 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. Economic Analysis [ Time Frame: 180 days ]
    Cost of each intervention

  8. Flap time [ Time Frame: During the surgery ]
    Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321201


Locations
Croatia
University Hospital Split Recruiting
Split, Croatia, 21000
Contact: Mladen Lesin, MD, PhD    0038521556111    mladen.lesin@gmail.com   
Contact    0038521556111    mladen.lesin@gmail.com   
Sponsors and Collaborators
University of Split, School of Medicine
University Hospital of Split

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Livia Puljak, Associate Professor, University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03321201     History of Changes
Other Study ID Numbers: PTERYGIUM1
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant data will be made available to other researchers on request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants