PterygiumNCT04151017
Efficacy of Autologous Fibrin Glue in Pterygium
A study testing Autologous fibrin glue and Suture in people with Pterygium, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Autologous fibrin glue and Suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jun 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nasal primary pterygium
Who cannot join
- relapsed pterygium
- patients with a history of previous eye surgery
- patients with glaucoma using hypotensive eye drops
- eye surface diseases
- eye allergy
- diabetic patients,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials
Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue.
OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture.
This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.
- Conditions
- Pterygium
- Being tested
- Autologous fibrin glue, Suture
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fibrin glueOther
Conjunctival graft fixation with autologous fibrin glue
SutureOther
Graft fixation using 10.0 mononylon
| Study group | Role | What they receive |
|---|---|---|
| Autologous fibrin glue | Experimental | Not described Receives: Other: Autologous fibrin glue |
| Sutures | Active comparator | Not described Receives: Other: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pterygium Recurrence
Recurrence in 6 months
Measured: 6 months
Secondary outcomes (3)
Autograft Retraction
Graft detachment or retraction
Measured: Postoperative day 1, 7, 21 and 30
Postoperative Pain
Presence Pain measured by a five-point scale, in which 0 means absence of symptom; 1 means easily tolerable symptom; 2 means symptom causing some discomfort; 3 means symptom partially interfering with usual activities and 4 means symptom completely interfering with usual activities
Measured: Postoperative day 1, 7, 21 and 30
Graft Edema
Graft edema (1-4).
Measured: Postoperative day 1, 7, 21 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start12 Jun 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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 PterygiumStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Diane Marinho, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151017
- Sponsor's protocol ID
- 20170467
- Status last verified
- Feb 2022
- First submitted
- 27 Sep 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cioba C, Marafon SB, Fortes BGB, Cavalheiro MT, Fabris M, Michel G, Zambon GM, Marcon A, Marinho DR. Autologous fibrin glue versus sutures for conjunctival autograft in primary pterygium: a randomized clinical trial. Int Ophthalmol. 2023 Jul;43(7):2371-2381. doi: 10.1007/s10792-023-02635-z. Epub 2023 Jan 18.
PubMed 36652022
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT04151017
- Acronym / sponsor ID
- 20170467
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Nov 2019 (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 wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue.
OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture.
This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous fibrin glue | Experimental | Other: Autologous fibrin glue |
| Sutures | Active comparator | Other: Suture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nasal primary pterygium
Key exclusion criteria (6 listed)
- relapsed pterygium
- patients with a history of previous eye surgery
- patients with glaucoma using hypotensive eye drops
- eye surface diseases
- eye allergy
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 |
|---|---|---|
| Autologous fibrin glueConjunctival graft fixation with autologous fibrin glue | Other | Autologous fibrin glue |
| SutureGraft fixation using 10.0 mononylon | Other | Sutures |
Primary outcome
Pterygium Recurrence
Time frame: 6 months
Recurrence in 6 months
3 secondary outcomes
Autograft Retraction
Time frame: Postoperative day 1, 7, 21 and 30
Postoperative Pain
Time frame: Postoperative day 1, 7, 21 and 30
Graft Edema
Time frame: Postoperative day 1, 7, 21 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Derived from this study: PubMed 36652022Cioba C, Marafon SB, Fortes BGB, Cavalheiro MT, Fabris M, Michel G, Zambon GM, Marcon A, Marinho DR. Autologous fibrin glue versus sutures for conjunctival autograft in primary pterygium: a randomized clinical trial. Int Ophthalmol. 2023 Jul;43(7):2371-2381. doi: 10.1007/s10792-023-02635-z. Epub 2023 Jan 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Diane Marinho principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous fibrin glue and Suture in people with Pterygium, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 14 Mar 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pterygium Recurrence (time frame: 6 months). 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 NCT04151017, 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 14 Mar 2022.