KeratoconusNCT04820608
Transepithelial Customized Cross-linking
A study testing Cross-linking in people with Keratoconus, run by Ophthalmica Eye Institute at 1 site in Greece.
Trial summary
Customized remodeled vision (CuRV) is a new corneal cross-linking protocol for keratoconus, combining a transepithelial approach with customized energy application. Our aim is to follow-up our patients and establish the short-and long-term results of CuRV. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Cross-linking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2018to 1 Jan 2022
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Topographic evidence of keratoconus:
- maximum corneal curvature (Kmax) ≥47.00 D,
- localized steepening on topographic maps,
- localized elevation in the anterior and posterior corneal surfaces.
Who cannot join
- Hypersensitivity to riboflavin
- Thinnest corneal pachymetry < 380 μm
- History of corneal surgery, including previous cross-linking
- Corneal scarring
- Aphakia
- Pseudophakia
- Any visually significant ocular condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epithelium-on Customized Cross-linking for Keratoconus
Customized remodeled vision (CuRV) is a new corneal cross-linking protocol for keratoconus, combining a transepithelial approach with customized energy application. Our aim is to follow-up our patients and establish the short-and long-term results of CuRV.
Read the detailed description
Customized remodeled vision is a protocol for oxygen-boosted, tranespithelial cross-linking, customized to apply higher energy at the apex of the cone, relatively lower to the cone area and none to healthy cornea. Thus CuRV promises to halt keratoconus progression, simultaneously offering potential for relatively good visual rehabilitation.Our primary outcomes involve spectacle-corrected distance visual acuity and changes in corneal topography/tomography and OCT parameters. These parameters include Kmax, thinnest corneal pachymetry, maximal anterior and posterior elevation, the Fourier analysis-derived irregularity index, and demarcation line depth.
- Conditions
- Keratoconus
- Being tested
- Cross-linking
- Keywords
- keratoconus, cross-linking, transepithelial, oxygen-boosted, customized, CXL
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-linkingDevice
Also called Customized remodeled vision
Oxygen-boosted, epithelium-on, customized cross-linking. Highest UV-A application is focused on the apex of the cone. The cone area receives a moderate amount of UV-A, while healthy cornea is spared.
| Study group | Role | What they receive |
|---|---|---|
| Customized, transepithelial cross-linking | Experimental | All study patients will be treated according to the customized remodeled vision protocol Receives: Device: Cross-linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectacle-corrected distance visual acuity
Measurements will be performed on Early Treatment of Diabetic Retinopathy Study charts in logMAR units
Measured: 1-3-6 months, 1 year, 2 years
Kmax
Maximal corneal keratometric value measured on Scheimpflung corneal tomography
Measured: 1-3-6 months, 1 year, 2 years
Secondary outcomes (5)
Demarcation line depth
Measurements will be performed at 1st postoperative month, when the demarcation line is most visible, on anterior segment optical coherence tomography. The measurement will be performed manually on the scan approximating the thinnest corneal location with the device-native caliper set at 1:1μm.
Measured: 1 month
Thinnest corneal pachymetry
Values as indicated on Scheimpflung corneal tomography device
Measured: 1-3-6 months, 1 year, 2 years
Maximal anterior & posterior elevation
Values as indicated on the Belin Ambrosio Enhanced Ectasia module of the Scheimpflung tomography device
Measured: 1-3-6 months, 1 year, 2 years
Fourier analysis-calculated maximum decentration
Values as indicated on the Fourier analysis module of the Scheimpflung tomography device
Measured: 1-3-6 months, 1 year, 2 years
Regularization index
Regularization index was proposed by Seiler et al. The measurement will be performed using the maximum flattening and steepening on the Comparison display of the Scheimpflung tomography device.
Measured: 1-3-6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Feb 2018
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmica Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miltos Balidis, PhD, Principal investigator, Ophthalmica Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820608
- Sponsor's protocol ID
- OphthalmicaEI
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seiler TG, Fischinger I, Koller T, Zapp D, Frueh BE, Seiler T. Customized Corneal Cross-linking: One-Year Results. Am J Ophthalmol. 2016 Jun;166:14-21. doi: 10.1016/j.ajo.2016.02.029. Epub 2016 Mar 2.
PubMed 26944278
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epithelium-on Customized Cross-linking for Keratoconus
- ClinicalTrials.gov ID
- NCT04820608
- Acronym / sponsor ID
- OphthalmicaEI
- Conditions
- Keratoconus
- Keywords
- keratoconus, cross-linking, transepithelial, oxygen-boosted, customized, CXL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ophthalmica Eye InstituteUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 29 Mar 2021 (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.
Customized remodeled vision (CuRV) is a new corneal cross-linking protocol for keratoconus, combining a transepithelial approach with customized energy application. Our aim is to follow-up our patients and establish the short-and long-term results of CuRV.
Detailed description
Customized remodeled vision is a protocol for oxygen-boosted, tranespithelial cross-linking, customized to apply higher energy at the apex of the cone, relatively lower to the cone area and none to healthy cornea. Thus CuRV promises to halt keratoconus progression, simultaneously offering potential for relatively good visual rehabilitation.Our primary outcomes involve spectacle-corrected distance visual acuity and changes in corneal topography/tomography and OCT parameters. These parameters include Kmax, thinnest corneal pachymetry, maximal anterior and posterior elevation, the Fourier analysis-derived irregularity index, and demarcation line depth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Customized, transepithelial cross-linking | Experimental | Device: Cross-linkingAll study patients will be treated according to the customized remodeled vision protocol |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Topographic evidence of keratoconus:
- maximum corneal curvature (Kmax) ≥47.00 D,
- localized steepening on topographic maps,
- localized elevation in the anterior and posterior corneal surfaces.
Key exclusion criteria (7 listed)
- Hypersensitivity to riboflavin
- Thinnest corneal pachymetry < 380 μm
- History of corneal surgery, including previous cross-linking
- Corneal scarring
- Aphakia
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 |
|---|---|---|
| Cross-linkingAlso: Customized remodeled visionOxygen-boosted, epithelium-on, customized cross-linking. Highest UV-A application is focused on the apex of the cone. The cone area receives a moderate amount of UV-A, while healthy cornea is spared. | Device | Customized, transepithelial cross-linking |
Primary outcome
Spectacle-corrected distance visual acuity
Time frame: 1-3-6 months, 1 year, 2 years
Measurements will be performed on Early Treatment of Diabetic Retinopathy Study charts in logMAR units
Kmax
Time frame: 1-3-6 months, 1 year, 2 years
Maximal corneal keratometric value measured on Scheimpflung corneal tomography
5 secondary outcomes
Demarcation line depth
Time frame: 1 month
Thinnest corneal pachymetry
Time frame: 1-3-6 months, 1 year, 2 years
Maximal anterior & posterior elevation
Time frame: 1-3-6 months, 1 year, 2 years
Fourier analysis-calculated maximum decentration
Time frame: 1-3-6 months, 1 year, 2 years
Regularization index
Time frame: 1-3-6 months, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Background: PubMed 26944278Seiler TG, Fischinger I, Koller T, Zapp D, Frueh BE, Seiler T. Customized Corneal Cross-linking: One-Year Results. Am J Ophthalmol. 2016 Jun;166:14-21. doi: 10.1016/j.ajo.2016.02.029. Epub 2016 Mar 2.
- 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.
Miltos Balidis, PhD principal investigator
Ophthalmica Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-linking in people with Keratoconus, run by Ophthalmica Eye Institute at 1 site in Greece.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Mar 2021. 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 Greece. 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?
Results are not available in the source record.
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?
Spectacle-corrected distance visual acuity (time frame: 1-3-6 months, 1 year, 2 years). 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?
On the ClinicalTrials.gov record for NCT04820608, which also lists 1 linked publication.
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 29 Mar 2021.