NCT03321201

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2018Dec 2026

First Submitted

Initial submission to the registry

October 16, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

May 8, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

7 years

First QC Date

October 16, 2017

Last Update Submit

November 1, 2022

Conditions

Pterygium of Conjunctiva and Cornea

Outcome Measures

Primary Outcomes (1)

  • Recurrence of pterygium

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

    180 days

Secondary Outcomes (8)

  • Surgical time

    During the surgery

  • Complication rate

    7, 30 and 180 days

  • Pterygium-induced astigmatism

    7, 30 and 180 days

  • Ocular surface condition

    7, 30 and 180 days

  • Postoperative discomfort, tearing, pain and foreign body sensation

    7, 30 and 180 days

  • +3 more secondary outcomes

Study Arms (2)

Cauterization

EXPERIMENTAL
Procedure: Cauterization

Fibrin glue

ACTIVE COMPARATOR
Procedure: Fibrin glue

Interventions

CauterizationPROCEDURE

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.

Cauterization
Fibrin gluePROCEDURE

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.

Fibrin glue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • connective tissue disease
  • prior eye surgery
  • chronic use of topical drugs (anti-glaucoma drugs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Split

Split, 21000, Croatia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29950464DERIVED

MeSH Terms

Conditions

Pterygium Of Conjunctiva And Cornea

Interventions

CauteryFibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, OperativeFibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 25, 2017

Study Start

May 8, 2018

Primary Completion

May 1, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Anonymized individual participant data will be made available to other researchers on request.

Locations

CR(1)