Efficacy of Autologous Fibrin Glue in Pterygium
Primary Purpose
Pterygium
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Autologous fibrin glue
Suture
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium
Eligibility Criteria
Inclusion Criteria:
- nasal primary pterygium
Exclusion Criteria:
- relapsed pterygium
- patients with a history of previous eye surgery
- patients with glaucoma using hypotensive eye drops
- eye surface diseases
- eye allergy
- diabetic patients,
Sites / Locations
- Santa Casa de Misericórdia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Autologous fibrin glue
Sutures
Arm Description
Outcomes
Primary Outcome Measures
Pterygium Recurrence
Recurrence in 6 months
Secondary Outcome Measures
Autograft Retraction
Graft detachment or retraction
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
Graft Edema
Graft edema (1-4).
Full Information
NCT ID
NCT04151017
First Posted
September 27, 2019
Last Updated
February 25, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT04151017
Brief Title
Efficacy of Autologous Fibrin Glue in Pterygium
Official Title
Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous fibrin glue
Arm Type
Experimental
Arm Title
Sutures
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Autologous fibrin glue
Intervention Description
Conjunctival graft fixation with autologous fibrin glue
Intervention Type
Other
Intervention Name(s)
Suture
Intervention Description
Graft fixation using 10.0 mononylon
Primary Outcome Measure Information:
Title
Pterygium Recurrence
Description
Recurrence in 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Autograft Retraction
Description
Graft detachment or retraction
Time Frame
Postoperative day 1, 7, 21 and 30
Title
Postoperative Pain
Description
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
Time Frame
Postoperative day 1, 7, 21 and 30
Title
Graft Edema
Description
Graft edema (1-4).
Time Frame
Postoperative day 1, 7, 21 and 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
nasal primary pterygium
Exclusion Criteria:
relapsed pterygium
patients with a history of previous eye surgery
patients with glaucoma using hypotensive eye drops
eye surface diseases
eye allergy
diabetic patients,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Marinho
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa de Misericórdia
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Autologous Fibrin Glue in Pterygium
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