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Omnigen in Acute Chemical Eye Injuries

Sponsor
Farwaniya Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05618522
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
14
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

evaluation of the role of Omnigen in acute chemical eye injuries

Condition or Disease Intervention/Treatment Phase
  • Procedure: vacuum-dehydrated amnion membrane (omnigen)
  • Device: the lens loaded with Omnigen
 N/A

Detailed Description

prospective interventional study included patients with different degrees of acute chemical eye injuries were treated by Omnigen and followed up for one month

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
prospectiveprospective
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Outcomes of Low Temperature Vacuum-dehydrated Amnion Membrane (Omnigen) in Treatment of Acute Chemical Eye Injuries
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Jul 1, 2022
Actual Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: the lens loaded with Omnigen

patients with acute chemical eye injury treated with omnigen

Procedure: vacuum-dehydrated amnion membrane (omnigen)
applying the lens loaded with Omnigen on the cornea
Other Names:
  • application of amnilenz

    • Device: the lens loaded with Omnigen
    the lens loaded with Omnigen

    Outcome Measures

    Primary Outcome Measures

    1. Epithelial healing [1 week]

      slit lamp examination with cobalt blue light after installing fluroscein drops

    2. limbal ischaemia [1 week]

      slit lamp examination of the clock hours of vascularity around the limbususing both Due classification and Roper Hall

    Secondary Outcome Measures

    1. omnigen tolerability [1 week]

      questionnaire for the patients asking about discomfort sensation or the need to patch the eye

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • acute chemical eye injury
    Exclusion Criteria:

    • absent or shallow fornices

    • symblepharon interfering with lens placement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Farwanyia Hospital Al Farwānīyah Farwanyia Kuwait 13001

    Sponsors and Collaborators

    • Farwaniya Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nancy Maher, Senior regsistrarof ophthalmology, Farwaniya Hospital
    ClinicalTrials.gov Identifier:
    NCT05618522
    Other Study ID Numbers:
    • Omnigen
    • associate professor
    First Posted:
    Nov 16, 2022
    Last Update Posted:
    Nov 16, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Nancy Maher, Senior regsistrarof ophthalmology, Farwaniya Hospital
    amniotic membrane
    chemical eye injury
    Additional relevant MeSH terms:
    Eye Injuries
    Wounds and Injuries

    Study Results

    No Results Posted as of Nov 16, 2022