Pack Cross Linking for Infectious Keratitis

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

Official Title
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Analysis of the Outcomes of Photoactivated Chromophore for Keratitis Cross _linking for Treatment of Infectious Keratitis

Conditions
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Infectoius Keratitis

Intervention / Treatment
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* Drug: Riboflavin
* Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan
* Device: pack cross linking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: groupA (control group)<br>will include 20 eyes of 20 patients with infectious keratitis who will receive antimicrobial therapy. | Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan<br>* topical application of antimicropial therapy<br>|
| Active Comparator: group B<br>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 | Drug: Riboflavin<br>* topical application of riboflavin followed by cross linking<br>Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan<br>* topical application of antimicropial therapy<br>Device: pack cross linking<br>* TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS<br>|
| Active Comparator: group C<br>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 | Drug: Riboflavin<br>* topical application of riboflavin followed by cross linking<br>Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan<br>* topical application of antimicropial therapy<br>Device: pack cross linking<br>* TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal THICKNESS | decrease corneal THICKNESS USING ANTERIOR SEGMENT OPTICAL COHERENT TOPOGRAPHY | within 60 days |