Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up.
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03753009 |
|
Recruitment Status :
Completed
First Posted : November 26, 2018
Last Update Posted : November 26, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Keratoconus | Procedure: corneal cross-linking |
| Study Type : | Observational |
| Actual Enrollment : | 28 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Iontophoretic Transepithelial Collagen Cross-linking Versus Epithelium-off Collagen Cross-linking in Pediatric Patients. Three Year Follow up. |
| Actual Study Start Date : | January 1, 2013 |
| Actual Primary Completion Date : | June 30, 2015 |
| Actual Study Completion Date : | June 30, 2015 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
|
Procedure: corneal cross-linking
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. |
|
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
|
Procedure: corneal cross-linking
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. |
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 9 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- clinical diagnosis of Keratoconus age < 18 years at the treatment; corneal cross linking performed at least 3 years before
Exclusion Criteria:
- age > 18 years at the treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753009
| Principal Investigator: | Luca Buzzonetti, MD | Bambino Gesù Children's Hospital, Rome, Italy |
| Responsible Party: | Luca Buzzonetti, Head of the Ophthalmology Department, Bambino Gesù IRCCS Children's Hospital, Rome, Italy, Bambino Gesù Hospital and Research Institute |
| ClinicalTrials.gov Identifier: | NCT03753009 |
| Other Study ID Numbers: |
PCXL |
| First Posted: | November 26, 2018 Key Record Dates |
| Last Update Posted: | November 26, 2018 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Keratoconus Corneal Diseases Eye Diseases |