Efficacy of Autologous Fibrin Glue in Pterygium
1 other identifier
interventional
64
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2019
CompletedFirst Submitted
Initial submission to the registry
September 27, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 14, 2022
February 1, 2022
1.5 years
September 27, 2019
February 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Pterygium Recurrence
Recurrence in 6 months
6 months
Secondary Outcomes (3)
Autograft Retraction
Postoperative day 1, 7, 21 and 30
Postoperative Pain
Postoperative day 1, 7, 21 and 30
Graft Edema
Postoperative day 1, 7, 21 and 30
Study Arms (2)
Autologous fibrin glue
EXPERIMENTALSutures
ACTIVE COMPARATORInterventions
Conjunctival graft fixation with autologous fibrin glue
Eligibility Criteria
You may qualify if:
- nasal primary pterygium
You may not qualify if:
- relapsed pterygium
- patients with a history of previous eye surgery
- patients with glaucoma using hypotensive eye drops
- eye surface diseases
- eye allergy
- diabetic patients,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Santa Casa de Misericórdia
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (1)
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.
PMID: 36652022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diane Marinho
Hospital de Clinicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2019
First Posted
November 5, 2019
Study Start
June 12, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
March 14, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share