Pterygium of Conjunctiva and CorneaNCT03321201
Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
A study testing Cauterization and Fibrin glue in people with Pterygium of Conjunctiva and Cornea, run by University of Split, School of Medicine at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium of Conjunctiva and Cornea
- What is being tested?
- Cauterization and Fibrin glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteCroatia
- Study dates
- 8 May 2018to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- connective tissue disease
- prior eye surgery
- chronic use of topical drugs (anti-glaucoma drugs)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Split
Split, 21000
Mladen Lesin, MD, PhD, 0038521556111, mladen.lesin@gmail.com
0038521556111, mladen.lesin@gmail.com
About this study
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.
- Conditions
- Pterygium of Conjunctiva and Cornea
- Being tested
- Cauterization, Fibrin glue
- Medical subject headings
- Pterygium Of Conjunctiva And Cornea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CauterizationProcedure or surgery
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 glueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cauterization | Experimental | Not described Receives: Procedure: Cauterization |
| Fibrin glue | Active comparator | Not described Receives: Procedure: Fibrin glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pterygium
Any re-growth of tissue from the area of excision across the limbus onto the cornea.
Measured: 180 days
Secondary outcomes (8)
Surgical time
Surgical time: total operational time required for completion of the operation (measured in minutes)
Measured: During the surgery
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
Measured: 7, 30 and 180 days
Pterygium-induced astigmatism
Measured as described by Hsu 2014
Measured: 7, 30 and 180 days
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.
Measured: 7, 30 and 180 days
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.
Measured: 7, 30 and 180 days
Pain
Numerical rating scale (NRS) ranging from 0 to 10, where 0 = No pain and 10 = Pain as intense as you can imagine.
Measured: 7, 30 and 180 days
Economic Analysis
Cost of each intervention
Measured: 180 days
Flap time
Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start8 May 2018
- Primary completion1 May 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pterygium of Conjunctiva and CorneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Split
- Responsible party
- Principal investigator, Livia Puljak, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321201
- Sponsor's protocol ID
- PTERYGIUM1
- Status last verified
- Nov 2022
- First submitted
- 16 Oct 2017
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data will be made available to other researchers on request.
Publications
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.
PubMed 29950464
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
- ClinicalTrials.gov ID
- NCT03321201
- Acronym / sponsor ID
- PTERYGIUM1
- Conditions
- Pterygium of Conjunctiva and Cornea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Collaborators
- University Hospital of Split
- Study start
- 8 May 2018 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cauterization | Experimental | Procedure: Cauterization |
| Fibrin glue | Active comparator | Procedure: Fibrin glue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- connective tissue disease
- prior eye surgery
- chronic use of topical drugs (anti-glaucoma drugs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CauterizationTo 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. | Procedure or surgery | Cauterization |
| Fibrin glueFiber 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. | Procedure or surgery | Fibrin glue |
Primary outcome
Recurrence of pterygium
Time frame: 180 days
Any re-growth of tissue from the area of excision across the limbus onto the cornea.
8 secondary outcomes
Surgical time
Time frame: During the surgery
Complication rate
Time frame: 7, 30 and 180 days
Pterygium-induced astigmatism
Time frame: 7, 30 and 180 days
Ocular surface condition
Time frame: 7, 30 and 180 days
Postoperative discomfort, tearing, pain and foreign body sensation
Time frame: 7, 30 and 180 days
Pain
Time frame: 7, 30 and 180 days
Economic Analysis
Time frame: 180 days
Flap time
Time frame: During the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 29950464Lesin 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.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data will be made available to other researchers on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cauterization and Fibrin glue in people with Pterygium of Conjunctiva and Cornea, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of pterygium (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03321201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.