NCT05881187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

May 3, 2023

Last Update Submit

May 29, 2023

Conditions

Infectoius Keratitis

Outcome Measures

Primary Outcomes (1)

  • corneal THICKNESS

    decrease corneal THICKNESS USING ANTERIOR SEGMENT OPTICAL COHERENT TOPOGRAPHY

    within 60 days

Study Arms (3)

groupA (control group)

ACTIVE COMPARATOR

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

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

group B

ACTIVE COMPARATOR

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: RiboflavinDrug: Antibotice.g vigamox ED Antifungal e.g DflucanDevice: pack cross linking

group C

ACTIVE COMPARATOR

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: RiboflavinDrug: Antibotice.g vigamox ED Antifungal e.g DflucanDevice: pack cross linking

Interventions

RiboflavinDRUG

topical application of riboflavin followed by cross linking

group Bgroup C
Antibotice.g vigamox ED Antifungal e.g DflucanDRUG

topical application of antimicropial therapy

group Bgroup CgroupA (control group)
pack cross linkingDEVICE

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

group Bgroup C

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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))

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 35610943BACKGROUND

  • 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.

    PMID: 26509768BACKGROUND

  • 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.

    PMID: 27096139BACKGROUND

  • 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.

    PMID: 15339215BACKGROUND

MeSH Terms

Interventions

Riboflavin

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological Factors

Central Study Contacts

mariam A mohamed, assistant lecteure

CONTACT

01150960676mariam-abdelmawgoud@med.sohag.edu.eg

mohamed i hafez, professor

CONTACT

01068559840

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecteurer opthalmology department sohag univerisity hospital

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 31, 2023

Study Start

June 15, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

EG(1)