Pack Cross Linking for Infectious Keratitis

Sohag University

Status: Not yet enrolling

Conditions: Infectoius Keratitis

Treatments: Device: pack cross linking; Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan; Drug: Riboflavin

Study type: Interventional

Funder types: Other

Identifiers

NCT05881187

Pack cross linking

Details and patient eligibility

About

The primary aim of this study is to investigate the efficiency of PACK_ CXL in treatment of infectious keratitis and analyze postoperative outcomes.

Enrollment: 60 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• are age ≥18 years, fungal, bacterial or mixed infectious keratitis, ulcer ≤ 4 mm in diameter and showing a maximum depth of 350 μm (as assessed by either optical coherence tomography (OCT))

Exclusion criteria

• age ≤18 years, viral infectious keratitis, non-infectiouskeratitis, melting corneal ulcers with impending perforation, corneal thickness < 400 μm (including the corneal epithelium) and systemic diseases or systemic surgery, single-eyed and immunosuppressed patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

groupA (control group)

Active Comparator group

Description:

will include 20 eyes of 20 patients with infectious keratitis who will receive antimicrobial therapy.

Treatment:

Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan

group B

Active Comparator group

Description:

will include 20 eyes of 20 patients with infectious keratitis who will undergo PACK accelerated cross-linking Protocol-1 (9 mW/cm2 for 10 minutes to achieve 5.4 J/cm2) followed by antimicrobial therapy

Treatment:

Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan

Drug: Riboflavin

Device: pack cross linking

group C

Active Comparator group

Description:

will include 20 eyes of 20 patients with infectious keratitis who will undergo PACK accelerated crosslinking Protocol-2 (18 mW/cm2 for 7 minutes to achieve 7.2 J/cm2) followed by antimicrobial therapy

Treatment:

Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan

Drug: Riboflavin

Device: pack cross linking