Infectious KeratitisNCT04383431
Cross-linking as Treatment in Infectious Keratitis
A study testing PACK-CXL in people with Infectious Keratitis, run by Sohag University at 1 site in Egypt.
Trial summary
To compare between SCXL and ACXL for treatment of infectious keratitis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Keratitis
- What is being tested?
- PACK-CXL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2020to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fungal infectious keratitis
- bacterial infectious keratitis
- Must be not responding to medication
Who cannot join
- Viral keratitis
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Cross-linking Versus Accelerated Photoactivated Chromophore Cross-linking (PACK-CXL) for Treatment of Infectious Keratitis: A Comparative Study
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
- Infectious Keratitis
- Being tested
- PACK-CXL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACK-CXLProcedure or surgery
Standard epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode.
| Study group | Role | What they receive |
|---|---|---|
| Standard CXL | Experimental | Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode. Receives: Procedure: PACK-CXL |
| Accelerated CXL | Experimental | Accelerated epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation continuous mode. Receives: Procedure: PACK-CXL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal healing
Reepithelization of corneal ulcer which is measured in mm by slitlamp examination
Measured: 3 months
Corneal edema
measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start2 Jun 2020
- Primary completion1 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious KeratitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mohammed Iqbal, Sohag University
- Investigators
- Mohammed Iqbal, MD. PhP, Principal investigator, 00201068559840
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383431
- Sponsor's protocol ID
- 4-9/12/2018
- Status last verified
- Jan 2023
- First submitted
- 27 Apr 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be allowed for sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Cross-linking Versus Accelerated Photoactivated Chromophore Cross-linking (PACK-CXL) for Treatment of Infectious Keratitis: A Comparative Study
- ClinicalTrials.gov ID
- NCT04383431
- Acronym / sponsor ID
- 4-9/12/2018
- Conditions
- Infectious Keratitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare between SCXL and ACXL for treatment of infectious keratitis
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard CXL | Experimental | Procedure: PACK-CXLStandard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode. |
| Accelerated CXL | Experimental | Procedure: PACK-CXLAccelerated epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation continuous mode. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Fungal infectious keratitis
- bacterial infectious keratitis
- Must be not responding to medication
Key exclusion criteria (2 listed)
- Viral keratitis
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACK-CXLStandard epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode. | Procedure or surgery | Accelerated CXL, Standard CXL |
Primary outcome
Corneal healing
Time frame: 3 months
Reepithelization of corneal ulcer which is measured in mm by slitlamp examination
Corneal edema
Time frame: 3 months
measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be allowed for sharing
Related trials for Infectious Keratitis
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Active, not recruitingPhase 3
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Bacterial Keratitis
Not yet recruitingPhase 3
RB-PDT for Fusarium Keratitis: The LUMIERE Study
Fusarium Keratitis
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Iqbal, MD. PhP principal investigator
00201068559840
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACK-CXL in people with Infectious Keratitis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal healing (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.