- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151017
Efficacy of Autologous Fibrin Glue in Pterygium
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil
- Santa Casa de Misericórdia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Autologous fibrin glue
|
Conjunctival graft fixation with autologous fibrin glue
|
Active Comparator: Sutures
|
Graft fixation using 10.0 mononylon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pterygium Recurrence
Time Frame: 6 months
|
Recurrence in 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autograft Retraction
Time Frame: Postoperative day 1, 7, 21 and 30
|
Graft detachment or retraction
|
Postoperative day 1, 7, 21 and 30
|
Postoperative Pain
Time Frame: Postoperative day 1, 7, 21 and 30
|
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
|
Postoperative day 1, 7, 21 and 30
|
Graft Edema
Time Frame: Postoperative day 1, 7, 21 and 30
|
Graft edema (1-4).
|
Postoperative day 1, 7, 21 and 30
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Diane Marinho, Hospital de Clínicas de Porto Alegre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170467
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on Autologous fibrin glue
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-
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-
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-
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-
Mansoura UniversityCompleted