KeratoconusNCT03661164
Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients
An observational study of Keratoconus, run by Luca Buzzonetti.
Trial summary
To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression Read more about this study
- Who is it for?
- Ages 8 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
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 May 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 8 to 18 years
- All sexes
- Child, Adult
Study population: Thirtyfive eyes of 22 consecutive pediatric patients (5 female and 17 male; mean age 14.3±2.5 [SD] years; range, 9 to 18 years) affected by keratoconus (diagnosis established accord-ing to global consensus on keratoconus and ectatic diseases) who underwent transepithelial corneal cross-linking by iontophoresis are enrolled in this retrospective study.
Who may be able to join
- clinical diagnosis of Keratoconus age < 18 years at the treatment iontophoretic corneal cross linking performed at least 3 years before
Who cannot join
- age > 18 years at the treatment
- I
About this study
Official title: Factors Influencing Keratoconus Progression After Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients: Three Year Follow up
To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression
Read the detailed description
Purpose: To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression.
Methods: Thirthyfive eyes of 22 consecutive pediatric patients (mean age 14.3±2.5 years) with keratoconus are evaluated in this retrospective study. Subgroup A and B are made up in function of progression in maximum K (Kmax,) defined as steepening of 1.0 diopter or more recorded three year after CXL. Corrected distance visual acuity (CDVA), spherical equivalent, topographic cone location, Kmax, posterior elevation of the thinnest point and thinnest point are evaluated. A paired Student t test is used to compare preoperative and 12, 24, and 36 month postoperative da-ta. A P value <0.05 was considered significant.
- 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
Iontophoretic corneal cross linking
What is being measured
The primary outcome is the main question the study is designed to answer.
: Preoperative Kmax
Simulated maximum K (Kmax) is 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
posterior elevation of the thinnest point
posterior elevation of the thinnest point is measured by a Sirius Scheimpflug camera (CSO, Firenze, Italy)
Measured: 3 years
cone location
The topographic cone location is assessed at the preoperative visit as follows : central for cor-neas having maximum K located within the central 3 mm and paracentral for corneas having maximum K located within the central 3 to 5 mm.
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 posted7 Sep 2018
- Study start1 May 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luca Buzzonetti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luca Buzzonetti, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661164
- Sponsor's protocol ID
- ICXL
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Keratoconus Progression After Iontophoretic Transepithelial Corneal Cross-linking in Pediatric Patients: Three Year Follow up
- ClinicalTrials.gov ID
- NCT03661164
- Acronym / sponsor ID
- ICXL
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Luca BuzzonettiUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 7 Sep 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 report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression
Detailed description
Purpose: To report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (CXL) to assess preoperative factors that may influence ectasia progression.
Methods: Thirthyfive eyes of 22 consecutive pediatric patients (mean age 14.3±2.5 years) with keratoconus are evaluated in this retrospective study. Subgroup A and B are made up in function of progression in maximum K (Kmax,) defined as steepening of 1.0 diopter or more recorded three year after CXL. Corrected distance visual acuity (CDVA), spherical equivalent, topographic cone location, Kmax, posterior elevation of the thinnest point and thinnest point are evaluated. A paired Student t test is used to compare preoperative and 12, 24, and 36 month postoperative da-ta. A P value <0.05 was considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Thirtyfive eyes of 22 consecutive pediatric patients (5 female and 17 male; mean age 14.3±2.5 [SD] years; range, 9 to 18 years) affected by keratoconus (diagnosis established accord-ing to global consensus on keratoconus and ectatic diseases) who underwent transepithelial corneal cross-linking by iontophoresis are enrolled in this retrospective study.
Key inclusion criteria (1 listed)
- clinical diagnosis of Keratoconus age < 18 years at the treatment iontophoretic corneal cross linking performed at least 3 years before
Key exclusion criteria (2 listed)
- age > 18 years at the treatment
- I
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 linkingIontophoretic corneal cross linking | Procedure or surgery | – |
Primary outcome
: Preoperative Kmax
Time frame: 3 years
Simulated maximum K (Kmax) is 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)
posterior elevation of the thinnest point
Time frame: 3 years
posterior elevation of the thinnest point is measured by a Sirius Scheimpflug camera (CSO, Firenze, Italy)
cone location
Time frame: 3 years
The topographic cone location is assessed at the preoperative visit as follows : central for cor-neas having maximum K located within the central 3 mm and paracentral for corneas having maximum K located within the central 3 to 5 mm.
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 11 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Luca Buzzonetti.
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 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 11 Sep 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?
: Preoperative Kmax (time frame: 3 years). The study lists 3 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 11 Sep 2018.