KeratoconusNCT03753009
Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.
An observational study of Keratoconus, run by Bambino Gesù Hospital and Research Institute.
Trial summary
To compare 3 year iontophoretic transepithelial corneal cross-linking (I-ON CXL) outcomes with epithelium-off collagen cross-linking (epi-off CXL)in pediatric patients. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- corneal cross-linking
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Jun 2015
- Phase
- Observational
- 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 9 to 18 years
- All sexes
- Child, Adult
Study population: Thirty eyes of 28 consecutive pediatric patients (7 female and 21 male; mean age 14.3±2.5 [SD] years; range, 9 to 18 years) affected by keratoconus (diagnosis established according to global consensus on keratoconus and ectatic diseases) who underwent iontophoresic transepithelial corneal cross-linking by or epithelium-off corneal cross-linking are enrolled in this retrospective study
Who may be able to join
- clinical diagnosis of Keratoconus age < 18 years at the treatment; corneal cross linking performed at least 3 years before
Who cannot join
- age > 18 years at the treatment
About this study
To compare 3 year iontophoretic transepithelial corneal cross-linking (I-ON CXL) outcomes with epithelium-off collagen cross-linking (epi-off CXL)in pediatric patients.
Read the detailed description
Forty eyes of 28 consecutive pediatric patients (mean age 14.3±2.5 [SD] years; range, 9 to 18 years) with keratoconus were enrolled in the study. Twenty eyes of 15 patients underwent I-ON CXL, while 20 eyes of 13 patients underwent epi-off CXL. Corrected distance visual acuity (CDVA), spherical equivalent, maximum keratometry (Kmax), posterior elevation of the thinnest point and thickness of the thinnest point mean values were evaluated. A Student t test was used to compare baseline and 12, 24, and 36 month postoperative data. Keratoconus progression in function of preoperative Kmax value and cone location was evaluated at 36 months.
- Conditions
- Keratoconus
- Being tested
- corneal cross-linking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal cross-linkingProcedure or surgery
Epithelium-off CXL was performed according to the Siena (Dresden modified) protocol: 2% pilocarpine was instilled 30 minutes before treatment, the epithelium was removed using a blunt knife. An isotonic solution of riboflavin 0.1% and dextran 20% was instilled for 10 minutes of corneal soaking before starting UV-A irradiation. The solution was administered every 3 minutes for a total of 30 minutes of UV-A exposure at 3mW/cm2.
The iontophoresis device was filled with a hypoosmolar riboflavin 0.1% dextran-free solution enriched with ethylenediaminetetraacetic acid and trometamol. The device was then connected to a constant current generator initially set at 0.5 mA and increased to 1.0 mA to find out the individual tolerance. Iontophoresis was then performed for 5 minutes. The corneal device was then removed before performing UVA irradiation. During the irradiation phase (10 mW/cm2 for 9 minutes), good fluorescence was clearly detectable. The total treatment time was 14 minutes.
| Study group | Role | What they receive |
|---|---|---|
| iontophoretic transepithelial corneal cross-linking (I-ON CXL) | Twenty eyes of 15 patients with keratoconus (mean age 13±3.5 [SD] years, range 9 to 18) underwent Iontophoresis epi-on CXL Receives: Procedure: corneal cross-linking | |
| epithelium-off collagen cross-linking (epi-off CXL) | Twenty eyes of 13 patients with keratoconus (14±4 [SD] years, range 10 to 18) underwent standard epi-off CXL Receives: Procedure: corneal cross-linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratoconus stability
To evaluate change of simulated maximum K (Kmax) that was calculated by a Sirius Scheimpflug camera (CSO, Firenze, Italy) by averaging the axial curvature from the fourth to the eighth Placido rings of the flattest and steepest meridians (the amplitude of the zone taken into consideration, therefore has a vari-able diameter depending on the curvature of the cornea, and the principal meridians are not nec-essarily 90 degrees away)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Jan 2013
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Buzzonetti, Bambino Gesù Hospital and Research Institute
- Investigators
- Luca Buzzonetti, MD, Principal investigator, Bambino Gesù Children's Hospital, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753009
- Sponsor's protocol ID
- PCXL
- Status last verified
- Nov 2018
- First submitted
- 22 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.
- ClinicalTrials.gov ID
- NCT03753009
- Acronym / sponsor ID
- PCXL
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 26 Nov 2018 (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 3 year iontophoretic transepithelial corneal cross-linking (I-ON CXL) outcomes with epithelium-off collagen cross-linking (epi-off CXL)in pediatric patients.
Detailed description
Forty eyes of 28 consecutive pediatric patients (mean age 14.3±2.5 [SD] years; range, 9 to 18 years) with keratoconus were enrolled in the study. Twenty eyes of 15 patients underwent I-ON CXL, while 20 eyes of 13 patients underwent epi-off CXL. Corrected distance visual acuity (CDVA), spherical equivalent, maximum keratometry (Kmax), posterior elevation of the thinnest point and thickness of the thinnest point mean values were evaluated. A Student t test was used to compare baseline and 12, 24, and 36 month postoperative data. Keratoconus progression in function of preoperative Kmax value and cone location was evaluated at 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iontophoretic transepithelial corneal cross-linking (I-ON CXL) | – | Procedure: corneal cross-linkingTwenty eyes of 15 patients with keratoconus (mean age 13±3.5 [SD] years, range 9 to 18) underwent Iontophoresis epi-on CXL |
| epithelium-off collagen cross-linking (epi-off CXL) | – | Procedure: corneal cross-linkingTwenty eyes of 13 patients with keratoconus (14±4 [SD] years, range 10 to 18) underwent standard epi-off CXL |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Thirty eyes of 28 consecutive pediatric patients (7 female and 21 male; mean age 14.3±2.5 [SD] years; range, 9 to 18 years) affected by keratoconus (diagnosis established according to global consensus on keratoconus and ectatic diseases) who underwent iontophoresic transepithelial corneal cross-linking by or epithelium-off corneal cross-linking are enrolled in this retrospective study
Key inclusion criteria (1 listed)
- clinical diagnosis of Keratoconus age < 18 years at the treatment; corneal cross linking performed at least 3 years before
Key exclusion criteria (1 listed)
- age > 18 years at the treatment
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 |
|---|---|---|
| corneal cross-linkingEpithelium-off CXL was performed according to the Siena (Dresden modified) protocol: 2% pilocarpine was instilled 30 minutes before treatment, the epithelium was removed using a blunt knife. An isotonic solution of riboflavin 0.1% and dextran 20% was instilled for 10 minutes of corneal soaking before starting UV-A irradiation. The solution was administered every 3 minutes for a total of 30 minutes of UV-A exposure at 3mW/cm2. The iontophoresis device was filled with a hypoosmolar riboflavin 0.1% dextran-free solution enriched with ethylenediaminetetraacetic acid and trometamol. The device was then connected to a constant current generator initially set at 0.5 mA and increased to 1.0 mA to find out the individual tolerance. Iontophoresis was then performed for 5 minutes. The corneal device was then removed before performing UVA irradiation. During the irradiation phase (10 mW/cm2 for 9 minutes), good fluorescence was clearly detectable. The total treatment time was 14 minutes. | Procedure or surgery | epithelium-off collagen cross-linking (epi-off CXL), iontophoretic transepithelial corneal cross-linking (I-ON CXL) |
Primary outcome
keratoconus stability
Time frame: 3 years
To evaluate change of simulated maximum K (Kmax) that was calculated by a Sirius Scheimpflug camera (CSO, Firenze, Italy) by averaging the axial curvature from the fourth to the eighth Placido rings of the flattest and steepest meridians (the amplitude of the zone taken into consideration, therefore has a vari-able diameter depending on the curvature of the cornea, and the principal meridians are not nec-essarily 90 degrees away)
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 26 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Luca Buzzonetti, MD principal investigator
Bambino Gesù Children's Hospital, Rome, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Bambino Gesù Hospital and Research Institute.
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 1 inclusion and 1 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 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
keratoconus stability (time frame: 3 years). 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 26 Nov 2018.