CompletedNCT04383431Updated Jan 18, 2023

Cross-linking as Treatment in Infectious Keratitis

An interventional study of PACK-CXL in Infectious Keratitis, sponsored by Sohag University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-01-18.

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

Phase: Not applicable
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Sex: All

Study summary

To compare between SCXL and ACXL for treatment of infectious keratitis

Read the detailed description

Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode (Group A). Accelerated CXL 11 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode (Group B).

Conditions studied

Infectious Keratitis

Browse trials for

Keratitis 108

In context

Keratitis

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

This study's enrollment of 37 is close to 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.

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

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
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

Fungal infectious keratitis
bacterial infectious keratitis
Must be not responding to medication

Exclusion criteria

Exclusion Criteria:

Viral keratitis
Pregnancy and lactation

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 37 participants (actual)

Study arms

Experimental
Standard CXL
Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode.
Procedure: PACK-CXL
Experimental
Accelerated CXL
Accelerated epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation continuous mode.
Procedure: PACK-CXL

Interventions

ProcedurePACK-CXL
Standard epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode.

What researchers measure

Primary outcomes

Corneal healing
Reepithelization of corneal ulcer which is measured in mm by slitlamp examination
Time frame: 3 months
Corneal edema
measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography
Time frame: 3 months

Study locations

1 site

Faculty of medicine
Sohag, 82425, Egypt

References and documents

Individual participant data

Plan to share: Yes — Individual participant data will be allowed for sharing

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: 12 months after end of study

Access criteria: Ophthalmologists are allowed for access of data. they should email the principal investigator via dr_m_iqbal@yahoo.com to get the permission after reviewing the qualifications and quality of request

No publications or documents are linked to this record.

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

Ran from Jun 2020 to primary completion in Jan 2023, 30 months.

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 30 months is above that.

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

Registered: Apr 27, 2020
First posted: May 12, 2020
StartActual: Jun 2, 2020
Primary completionActual: Jan 1, 2023
CompletionActual: Jan 15, 2023
Last update: Jan 18, 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 Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04383431
Lead sponsor: Sohag University
Responsible party: Prof. Mohammed Iqbal (Assistant Professor of Ophthalmology, Sohag University) — Principal investigator
First posted: May 12, 2020
Start date: Jun 2, 2020
Primary completion: Jan 1, 2023
Completion: Jan 15, 2023
Last update: Jan 18, 2023

Study contacts

Mohammed Iqbal, MD. PhP

principal investigator · 00201068559840

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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