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NCT Number: NCT03321201

Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

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.

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Key information

Conditions

Pterygium of Conjunctiva and Cornea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cauterization

Procedure

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

Procedure

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Collaborators

  • University Hospital of Split

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Oct 25, 2017
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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