Omnigen in Acute Chemical Eye Injuries (Omnigen)

November 15, 2022 updated by: Nancy Maher, Farwaniya Hospital

Clinical Outcomes of Low Temperature Vacuum-dehydrated Amnion Membrane (Omnigen) in Treatment of Acute Chemical Eye Injuries

evaluation of the role of Omnigen in acute chemical eye injuries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
    • Farwanyia
      • Al Farwānīyah, Farwanyia, Kuwait, 13001
        • Farwanyia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute chemical eye injury

Exclusion Criteria:

  • absent or shallow fornices
  • symblepharon interfering with lens placement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelial healing
Time Frame: 1 week
slit lamp examination with cobalt blue light after installing fluroscein drops
1 week
limbal ischaemia
Time Frame: 1 week
slit lamp examination of the clock hours of vascularity around the limbususing both Due classification and Roper Hall
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
omnigen tolerability
Time Frame: 1 week
questionnaire for the patients asking about discomfort sensation or the need to patch the eye
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farwaniya Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Omnigen
  • associate professor (Nancy Maher)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

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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