Pack Cross Linking for Infectious Keratitis

NCT ID: NCT05881187

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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Infectoius Keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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groupA (control group)

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

Group Type ACTIVE_COMPARATOR

Antibotice.g vigamox ED Antifungal e.g Dflucan

Intervention Type DRUG

topical application of antimicropial therapy

group B

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

Group Type ACTIVE_COMPARATOR

Riboflavin

Intervention Type DRUG

topical application of riboflavin followed by cross linking

Antibotice.g vigamox ED Antifungal e.g Dflucan

Intervention Type DRUG

topical application of antimicropial therapy

pack cross linking

Intervention Type DEVICE

TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS

group C

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

Group Type ACTIVE_COMPARATOR

Riboflavin

Intervention Type DRUG

topical application of riboflavin followed by cross linking

Antibotice.g vigamox ED Antifungal e.g Dflucan

Intervention Type DRUG

topical application of antimicropial therapy

pack cross linking

Intervention Type DEVICE

TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS

Interventions

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Riboflavin

topical application of riboflavin followed by cross linking

Intervention Type DRUG

Antibotice.g vigamox ED Antifungal e.g Dflucan

topical application of antimicropial therapy

Intervention Type DRUG

pack cross linking

TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS

Intervention Type DEVICE

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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Abdelmawgoud Mohamed

assistant lecteurer opthalmology department sohag univerisity hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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mariam A mohamed, assistant lecteure

Role: CONTACT

01150960676

mohamed i hafez, professor

Role: CONTACT

01068559840

Facility Contacts

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magdy m ameen, professor

Role: primary

References

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Cabrera-Aguas M, Khoo P, Watson SL. Infectious keratitis: A review. Clin Exp Ophthalmol. 2022 Jul;50(5):543-562. doi: 10.1111/ceo.14113. Epub 2022 Jun 3.

Reference Type BACKGROUND
PMID: 35610943 (View on PubMed)

Papaioannou L, Miligkos M, Papathanassiou M. Corneal Collagen Cross-Linking for Infectious Keratitis: A Systematic Review and Meta-Analysis. Cornea. 2016 Jan;35(1):62-71. doi: 10.1097/ICO.0000000000000644.

Reference Type BACKGROUND
PMID: 26509768 (View on PubMed)

Tabibian D, Mazzotta C, Hafezi F. PACK-CXL: Corneal cross-linking in infectious keratitis. Eye Vis (Lond). 2016 Apr 19;3:11. doi: 10.1186/s40662-016-0042-x. eCollection 2016.

Reference Type BACKGROUND
PMID: 27096139 (View on PubMed)

Kumar V, Lockerbie O, Keil SD, Ruane PH, Platz MS, Martin CB, Ravanat JL, Cadet J, Goodrich RP. Riboflavin and UV-light based pathogen reduction: extent and consequence of DNA damage at the molecular level. Photochem Photobiol. 2004 Jul-Aug;80:15-21. doi: 10.1562/2003-12-23-RA-036.1.

Reference Type BACKGROUND
PMID: 15339215 (View on PubMed)

Other Identifiers

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Pack cross linking

Identifier Type: -

Identifier Source: org_study_id

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