Role of giving peribulbar eye injection of amphotericin b for eye component of disease entity called invasive rhino-orbital mucor-mycosis as an early treatmnet

Not Applicable

• Conditions: Health Condition 1: H050- Acute inflammation of orbit

• Registration Number: CTRI/2022/04/042226
• Lead Sponsor: Guru Teg Bahadur Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Type A - Sub-clinical Rhino-orbital Mucormycosis cases - All cases being admitted at Guru Teg Bahadur Hospital, New Delhi have symptoms of Rhino-Mucormycosis with bony erosion of the (wall/walls) of orbit with orbital fat stranding or others, suggestive of breach of the orbital cavity on contrast-enhanced Computerized tomography.

Symptoms of Rhino-Mucormycosis:

1 Nasal stuffiness

2 Foul smell

3 Epistaxis

4 Nasal discharge - mucoid, purulent, blood-tinged or black

5 Nasal mucosal erythema, inflammation, purple or blue discolouration, white ulcer, ischemia, or eschar

The cases fulfilling the above criteria shall undergo microbiological confirmation for Mucorales before being recruited into group A.

Type B - Early Rhino-orbital Mucormycosis cases- This study shall also include all cases being admitted at Guru Teg Bahadur Hospital, New Delhi having symptoms of early Rhino-orbital Mucormycosis.

Definition of early clinical cases: Patients having subtle ocular signs having disease limited to extraconal compartment as seen on imaging.

1 Eyelid, periocular edema

2 Mild ptosis

3 Mild Ocular motility restriction

4 Facial paresthesia, anesthesia (infraorbital)

The cases fulfilling the above criteria shall undergo microbiological confirmation for Mucorales before being recruited into group B.

Microbiological confirmation - All cases would be confirmed for Mucorales by microbiological direct microscopy of samples drawn from deep nasal swabs or endoscopic guided nasal swabs or nasal biopsy as a part of the standard of care

Exclusion Criteria

1. Rhino-orbital Mucor mycosis patients having intraconal orbital involvement as seen on imaging.

2. Rhino-orbital Mucor mycosis patients having extraconal orbital involvement with best-corrected visual acuity less than 6/6.

Study & Design

• Study Type: Interventional
• Study Design: Not specified