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A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery

Primary Purpose

Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conjunctival autograft with fibrin glue
sutured conjunctival autograft
sutureless and glue-free conjunctival autograft
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients complaining of primary Progressive nasal pterygium.
  2. Patients with pterygium threatening the visual axis.

Exclusion Criteria:

  1. Double head pterygium.
  2. Pseudopterygium
  3. Recurrent pterygium
  4. Patients with history of any bleeding abnormalities
  5. Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    conjunctival autograft with fibrin glue

    sutured conjunctival autograft

    sutureless and glue-free conjunctival autograft

    Arm Description

    Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision

    Sutured conjunctival autograft done for patients of group 2 after pterygium excision

    Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision

    Outcomes

    Primary Outcome Measures

    Recurrence Rate
    The main postoperative primary outcomes measure the recurrence rate

    Secondary Outcome Measures

    Graft stability
    postoperative Graft stability rated from grade 0 to 4 using a 5 point scale
    Postoperative inflammation
    postoperative inflammation rated from grade 0 to 4 using a 5 point scale
    Postoperative discomfort
    postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)
    Overall patient satisfaction
    Overall satisfaction with the procedure 4 weeks post-operatively will recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The three groups will compared for overall satisfaction.
    Complications
    Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.

    Full Information

    First Posted
    September 27, 2017
    Last Updated
    January 8, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03301974
    Brief Title
    A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
    Official Title
    A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 24, 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.
    Detailed Description
    Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital & El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).

    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
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    conjunctival autograft with fibrin glue
    Arm Type
    Experimental
    Arm Description
    Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
    Arm Title
    sutured conjunctival autograft
    Arm Type
    Experimental
    Arm Description
    Sutured conjunctival autograft done for patients of group 2 after pterygium excision
    Arm Title
    sutureless and glue-free conjunctival autograft
    Arm Type
    Experimental
    Arm Description
    Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision
    Intervention Type
    Procedure
    Intervention Name(s)
    conjunctival autograft with fibrin glue
    Intervention Description
    Simple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1).
    Intervention Type
    Procedure
    Intervention Name(s)
    sutured conjunctival autograft
    Intervention Description
    Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2).
    Intervention Type
    Procedure
    Intervention Name(s)
    sutureless and glue-free conjunctival autograft
    Intervention Description
    Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)
    Primary Outcome Measure Information:
    Title
    Recurrence Rate
    Description
    The main postoperative primary outcomes measure the recurrence rate
    Time Frame
    6 months postoperatively
    Secondary Outcome Measure Information:
    Title
    Graft stability
    Description
    postoperative Graft stability rated from grade 0 to 4 using a 5 point scale
    Time Frame
    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
    Title
    Postoperative inflammation
    Description
    postoperative inflammation rated from grade 0 to 4 using a 5 point scale
    Time Frame
    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
    Title
    Postoperative discomfort
    Description
    postoperative discomfort rated from 0 to 10 on the Visual Analogue Scale (VAS)
    Time Frame
    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
    Title
    Overall patient satisfaction
    Description
    Overall satisfaction with the procedure 4 weeks post-operatively will recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The three groups will compared for overall satisfaction.
    Time Frame
    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively
    Title
    Complications
    Description
    Complications recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.
    Time Frame
    1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients complaining of primary Progressive nasal pterygium. Patients with pterygium threatening the visual axis. Exclusion Criteria: Double head pterygium. Pseudopterygium Recurrent pterygium Patients with history of any bleeding abnormalities Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.

    12. IPD Sharing Statement

    Learn more about this trial

    A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery

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