Back to resultsOmnigen in Acute Chemical Eye Injuries (Omnigen)
Primary Purpose
Acute Chemical Eye Injuries
Status
Completed
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
vacuum-dehydrated amnion membrane (omnigen)
the lens loaded with Omnigen
Sponsored by
About this trial
This is an interventional treatment trial for Acute Chemical Eye Injuries focused on measuring amniotic membrane, chemical eye injury
Eligibility Criteria
Inclusion Criteria: acute chemical eye injury Exclusion Criteria: absent or shallow fornices symblepharon interfering with lens placement
Sites / Locations
- Farwanyia Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
the lens loaded with Omnigen
Arm Description
patients with acute chemical eye injury treated with omnigen
Outcomes
Primary Outcome Measures
Epithelial healing
slit lamp examination with cobalt blue light after installing fluroscein drops
limbal ischaemia
slit lamp examination of the clock hours of vascularity around the limbususing both Due classification and Roper Hall
Secondary Outcome Measures
omnigen tolerability
questionnaire for the patients asking about discomfort sensation or the need to patch the eye
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05618522
Brief Title
Omnigen in Acute Chemical Eye Injuries
Acronym
Omnigen
Official Title
Clinical Outcomes of Low Temperature Vacuum-dehydrated Amnion Membrane (Omnigen) in Treatment of Acute Chemical Eye Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Farwaniya Hospital
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
Yes
5. Study Description
Brief Summary
evaluation of the role of Omnigen in acute chemical eye injuries
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Chemical Eye Injuries
Keywords
amniotic membrane, chemical eye injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the lens loaded with Omnigen
Arm Type
Other
Arm Description
patients with acute chemical eye injury treated with omnigen
Intervention Type
Procedure
Intervention Name(s)
vacuum-dehydrated amnion membrane (omnigen)
Other Intervention Name(s)
application of amnilenz
Intervention Description
applying the lens loaded with Omnigen on the cornea
Intervention Type
Device
Intervention Name(s)
the lens loaded with Omnigen
Intervention Description
the lens loaded with Omnigen
Primary Outcome Measure Information:
Title
Epithelial healing
Description
slit lamp examination with cobalt blue light after installing fluroscein drops
Time Frame
1 week
Title
limbal ischaemia
Description
slit lamp examination of the clock hours of vascularity around the limbususing both Due classification and Roper Hall
Time Frame
1 week
Secondary Outcome Measure Information:
Title
omnigen tolerability
Description
questionnaire for the patients asking about discomfort sensation or the need to patch the eye
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute chemical eye injury
Exclusion Criteria:
absent or shallow fornices
symblepharon interfering with lens placement
Facility Information:
Facility Name
Farwanyia Hospital
City
Al Farwānīyah
State/Province
Farwanyia
ZIP/Postal Code
13001
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Omnigen in Acute Chemical Eye Injuries
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