NCT05618522

Brief Summary

evaluation of the role of Omnigen in acute chemical eye injuries

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 9, 2022

Last Update Submit

November 15, 2022

Conditions

Acute Chemical Eye Injuries

Keywords

amniotic membranechemical eye injury

Outcome Measures

Primary Outcomes (2)

  • Epithelial healing

    slit lamp examination with cobalt blue light after installing fluroscein drops

    1 week

  • limbal ischaemia

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

    1 week

Secondary Outcomes (1)

  • omnigen tolerability

    1 week

Study Arms (1)

the lens loaded with Omnigen

OTHER

patients with acute chemical eye injury treated with omnigen

Procedure: vacuum-dehydrated amnion membrane (omnigen)Device: the lens loaded with Omnigen

Interventions

vacuum-dehydrated amnion membrane (omnigen)PROCEDURE

applying the lens loaded with Omnigen on the cornea

Also known as: application of amnilenz
the lens loaded with Omnigen
the lens loaded with OmnigenDEVICE

the lens loaded with Omnigen

the lens loaded with Omnigen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute chemical eye injury

You may not qualify if:

  • absent or shallow fornices
  • symblepharon interfering with lens placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farwanyia Hospital

Al Farwānīyah, Farwanyia, 13001, Kuwait

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior regsistrarof ophthalmology

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 16, 2022

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

KU(1)