Evaluation of the Safety and Effectiveness of omniLenz in Patient With Ocular Graft vs Host Disease

Farwaniya Hospital3 enrolled

Overview

A case series of patients presented with graft versus host disease with ocular involvement . The study recruited a total of 3 patients who were referred to cornea clinic of Farwaniya Hospital, Kuwait between April 2022 and April 2024. All cases presented with severe dryness, spks and corneal epithelial defect not responding to other measures of treatment. An OmniLenz was applied for each patient for one week. Primary outcome measures included healing of the corneal resistant epithelial defect, secondary outcome measures were improvement of signs of dryness.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ocular Graft Versus Host Disease

Interventions

omniLenzDEVICE

sutureless dehydrated amniotic membrane (omnigen) mounted on contact lens (omnilenz)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of Ocular graft versus host disease Exclusion Criteria: \- Patient with conjunctival fibrosis and symblephara formation (which interfere with application of the omnilenz)

Locations (1)

Farwanyia Hospital

Al Farwānīyah, Kuwait

Outcomes

Primary Outcomes

Epithelial healing, Slit lamp examination with cobalt blue light after installation of fluorescein eye drops

Time frame: 1 week ( duration of the application of omnilenz )

Secondary Outcomes

Omnigen tolerability, Questionnaire for the patients asking about discomfort sensation or the need to patch the eye

Time frame: 1 week ( duration of the application of omnilenz )

Data from ClinicalTrials.gov

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