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Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium

Primary Purpose

Recurrent Pterygium of Eye

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conjunctival autografting augmented with topical application of Mitomycin C
conjunctival autografting augmented with Ologen implantation
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Pterygium of Eye

Eligibility Criteria

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

Inclusion Criteria:

recurrent nasal pterygium after one surgical session for removal of the primary one

Exclusion Criteria:

  • primary nasal pterygium,
  • recurrent pterygium with more than one session for surgical removal

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    conjunctival autografting with MMC

    conjunctival autografting augmented with Ologen implantation

    Arm Description

    Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).

    Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

    Outcomes

    Primary Outcome Measures

    32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
    As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution).
    31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.
    In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 14, 2020
    Last Updated
    June 2, 2020
    Sponsor
    Menoufia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04419038
    Brief Title
    Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium
    Official Title
    Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 2016 (Actual)
    Primary Completion Date
    December 1, 2019 (Actual)
    Study Completion Date
    December 30, 2019 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Ologen implantation with conjunctival autografting shows promising results in surgical management of recurrent pterygium comparable to MMC application with conjunctival autografting with mild non vision threatening postoperative complications.
    Detailed Description
    Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL). Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation. All patients had a recurrent nasal pterygium after one surgical session for removal of the primary one. Any patient with primary nasal pterygium, or patients with recurrent pterygium who had more than one session for surgical removal were excluded. As well, patients with cicatrizing conjunctival disease or previous conjunctival surgery were excluded from the study. A comprehensive ophthalmic examination, including best-corrected visual acuity testing, slit-lamp examination, Goldmann applanation tonometry, fundus examination, and examination of ocular motility, was carried out for all patients. According to their corneal extent, pterygia were classified into 3 grades: Grade 1: Fibrovascular proliferations extend up to one quarter of the corneal diameter. Grade 2: Fibrovascular proliferations extend up to the center of the cornea. Grade 3: Fibrovascular proliferations extend beyond the visual axis. Consents were taken from all patients and research was approved by the institutional review board. All measures were in accordance with the tenets of the Declaration of Helsinki. As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution). This solution is stable for 2 weeks under refrigeration, and 24 hours at room temperature (59° to 86°F). As for group B, 1×2 or 2×2 square millimeter porous collagen matrix was used for each patient

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Pterygium of Eye

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    conjunctival autografting with MMC
    Arm Type
    Active Comparator
    Arm Description
    Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
    Arm Title
    conjunctival autografting augmented with Ologen implantation
    Arm Type
    Active Comparator
    Arm Description
    Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
    Intervention Type
    Procedure
    Intervention Name(s)
    conjunctival autografting augmented with topical application of Mitomycin C
    Intervention Description
    Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
    Intervention Type
    Procedure
    Intervention Name(s)
    conjunctival autografting augmented with Ologen implantation
    Intervention Description
    Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
    Primary Outcome Measure Information:
    Title
    32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
    Description
    As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution).
    Time Frame
    "through study completion, an average of 1 year".
    Title
    31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.
    Description
    In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)
    Time Frame
    "through study completion, an average of 1 year".

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: recurrent nasal pterygium after one surgical session for removal of the primary one Exclusion Criteria: primary nasal pterygium, recurrent pterygium with more than one session for surgical removal

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33505715
    Citation
    Wagdy FM, Farahat HG, Ellakwa AF, Mandour SS. Evaluation of Conjunctival Autografting Augmented with Mitomycin C Application versus Ologen Implantation in the Surgical Treatment of Recurrent Pterygium. J Ophthalmol. 2021 Jan 12;2021:8820926. doi: 10.1155/2021/8820926. eCollection 2021.
    Results Reference
    derived

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    Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium

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