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Pack Cross Linking for Infectious Keratitis

Not Applicable
Not yet recruiting
Conditions
Infectoius Keratitis
Interventions
Drug: Riboflavin
Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan
Device: pack cross linking
Registration Number
NCT05881187
Lead Sponsor
Sohag University
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
60
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))
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
group CAntibotice.g vigamox ED Antifungal e.g Dflucanwill 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
groupA (control group)Antibotice.g vigamox ED Antifungal e.g Dflucanwill include 20 eyes of 20 patients with infectious keratitis who will receive antimicrobial therapy.
group Bpack cross linkingwill 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
group BAntibotice.g vigamox ED Antifungal e.g Dflucanwill 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
group Cpack cross linkingwill 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
group BRiboflavinwill 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
group CRiboflavinwill 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
Primary Outcome Measures
NameTimeMethod
corneal THICKNESSwithin 60 days

decrease corneal THICKNESS USING ANTERIOR SEGMENT OPTICAL COHERENT TOPOGRAPHY

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sohag University Hospital

🇪🇬

Sohag, Egypt

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