ClinicalTrials.gg
Not yet recruitingNCT05881187Updated May 31, 2023

Pack Cross Linking for Infectious Keratitis

An interventional study of Riboflavin and Antibotice.g vigamox ED Antifungal e.g Dflucan in Infectoius Keratitis, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Infectoius Keratitis

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03

In context

Keratitis

108 studies on the registry are indexed under Keratitis; 19 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 70 interventional studies indexed under Keratitis.

Browse Keratitis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 patients.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    groupA (control group)

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

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

  • Active comparator
    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

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

  • Active comparator
    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

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

Interventions

  • topical application of riboflavin followed by cross linking

  • DrugAntibotice.g vigamox ED Antifungal e.g Dflucan

    topical application of antimicropial therapy

  • Devicepack cross linking

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

06

What researchers measure

Primary outcomes

  1. corneal THICKNESS

    decrease corneal THICKNESS USING ANTERIOR SEGMENT OPTICAL COHERENT TOPOGRAPHY

    Time frame: within 60 days

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 35610943 ↗
  • 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. PubMed 26509768 ↗
  • 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. PubMed 27096139 ↗
  • 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. PubMed 15339215 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2023; primary completion for Apr 2024, 10 months later.

Of 12 interventional studies with no phase under Keratitis, half reached primary completion within 20 months of starting (the median); a quarter within 5 and three quarters within 24. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2023
First posted
May 31, 2023
StartEst.
Jun 15, 2023
Primary completionEst.
Apr 2024
CompletionEst.
Jun 2024
Last update
May 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05881187
Lead sponsor
Sohag University
Responsible party
Mariam Abdelmawgoud Mohamed (assistant lecteurer opthalmology department sohag univerisity hospital, Sohag University) — Principal investigator
First posted
May 31, 2023
Start date
Jun 15, 2023 (estimated)
Primary completion
Apr 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
May 31, 2023

Study contacts

mariam A mohamed, assistant lecteure
Contact
mariam-abdelmawgoud@med.sohag.edu.eg
01150960676
mohamed i hafez, professor
Contact
01068559840

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Riboflavin

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