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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

Efficacy of using peribulbar injection of amphotericin b for invasive rhino-orbital mucor-mycosis ââ?¬â?? A pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042226
Enrollment
15
Registered
2022-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H050- Acute inflammation of orbit

Interventions

Intervention1: Peribulbar injection of amphotericin b: The patients having Rhino-orbital Mucormycosis along with standard of care patient shall receive extraconal inta-orbital local injections of Amph

Sponsors

Guru Teg Bahadur Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Outcome parameters: For group A: Improvement in radiological parameters and non-progression of disease into the intraconal compartment of orbit. For group B: Resolution of disease: Complete improvement in presenting ocular signs in patients having disease limited to extraconal compartment as seen on imaging.Timepoint: Outcome parameters to be assessed daily during intervention and at the end of 4 weeks

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Ankur Singh

The University College of Medical Sciences and GTB hospital

drankursingh1@gmail.com9878799215

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026