KeratoconusNCT06159881
Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus
A study testing Corneal Cross Linking in people with Keratoconus, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
The goal of this clinical trial is to document corneal ectasia stability in patients with keratoconus diagnosis treated with personalized cross linking energy. The main questions it aims to answer are: Is it effective while using personalized (reduced) energy? Is it safe for corneas thinner than 400 microns?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal Cross Linking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2023to 15 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Keratoconus diagnosed with corneal tomography/topography
- Thinnest point pachymetry below 400 microns
Who cannot join
- Previous corneal cross linking history
- Corneal scars not allowing best corrected visual acuity of 20/100 or better
- Previous corneal hydrops history
- Psychomotor retardation history
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto de Oftalmología Conde de Valenciana
Mexico City
Enrique Graue, 55 5442 1700, egraueh@gmail.com
About this study
Official title: Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus Corneas
The goal of this clinical trial is to document corneal ectasia stability in patients with keratoconus diagnosis treated with personalized cross linking energy. The main questions it aims to answer are:
- Is it effective while using personalized (reduced) energy?
- Is it safe for corneas thinner than 400 microns? Participants will be treated with personalized energy corneal cross linking and posteriorly, will attend subsequent follow-up consults
- Conditions
- Keratoconus
- Being tested
- Corneal Cross Linking
- Keywords
- Progression, Customized, Cross-Linking
- Medical subject headings
- Keratoconus, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Cross LinkingProcedure or surgery
Total fluence adapted to thinnest point pachymetry
| Study group | Role | What they receive |
|---|---|---|
| Personalized cross linking | Experimental | Participants were treated with personalized energy cross linking according to their thinnest point corneal pachymetry Receives: Procedure: Corneal Cross Linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratometry stability
Stability documented by changes in keratometries (measured in diopters) obtained with corneal tomography, as well as uncorrected visual acuity observed in follow up consults
Measured: Baseline and 6 months
Pachymetry stability
Stability documented by changes in pachymetry (measured in microns) obtained with corneal tomography
Measured: Baseline and 6 months
Uncorrected visual acuity stability
Stability documented by changes in uncorrected visual acuity (measured in logarithm of the minimum angle of resolution) obtained on physical examiantion
Measured: Baseline, 72 hours, 1 week, 3 months and 6 months
Corneal endothelium safety
Corneal endothelial cell count obtained by specular microscopy
Measured: Baseline, 72 hours, 1 week, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Mar 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Graue, MD, MSc, Study director, Instituto de Oftalmología Conde de Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159881
- Sponsor's protocol ID
- 17 CI 09 015 008
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hafezi F, Kling S, Gilardoni F, Hafezi N, Hillen M, Abrishamchi R, Gomes JAP, Mazzotta C, Randleman JB, Torres-Netto EA. Individualized Corneal Cross-linking With Riboflavin and UV-A in Ultrathin Corneas: The Sub400 Protocol. Am J Ophthalmol. 2021 Apr;224:133-142. doi: 10.1016/j.ajo.2020.12.011. Epub 2021 Jan 30.
PubMed 33340508Lang PZ, Hafezi NL, Khandelwal SS, Torres-Netto EA, Hafezi F, Randleman JB. Comparative Functional Outcomes After Corneal Crosslinking Using Standard, Accelerated, and Accelerated With Higher Total Fluence Protocols. Cornea. 2019 Apr;38(4):433-441. doi: 10.1097/ICO.0000000000001878.
PubMed 30681515Nath S, Shen C, Koziarz A, Banfield L, Nowrouzi-Kia B, Fava MA, Hodge WG. Transepithelial versus Epithelium-off Corneal Collagen Cross-linking for Corneal Ectasia: A Systematic Review and Meta-analysis. Ophthalmology. 2021 Aug;128(8):1150-1160. doi: 10.1016/j.ophtha.2020.12.023. Epub 2020 Dec 28.
PubMed 33383093
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus Corneas
- ClinicalTrials.gov ID
- NCT06159881
- Acronym / sponsor ID
- 17 CI 09 015 008
- Conditions
- Keratoconus
- Keywords
- Progression, Customized, Cross-Linking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 7 Dec 2023 (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.
The goal of this clinical trial is to document corneal ectasia stability in patients with keratoconus diagnosis treated with personalized cross linking energy. The main questions it aims to answer are:
- Is it effective while using personalized (reduced) energy?
- Is it safe for corneas thinner than 400 microns? Participants will be treated with personalized energy corneal cross linking and posteriorly, will attend subsequent follow-up consults
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized cross linking | Experimental | Procedure: Corneal Cross LinkingParticipants were treated with personalized energy cross linking according to their thinnest point corneal pachymetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Keratoconus diagnosed with corneal tomography/topography
- Thinnest point pachymetry below 400 microns
Key exclusion criteria (4 listed)
- Previous corneal cross linking history
- Corneal scars not allowing best corrected visual acuity of 20/100 or better
- Previous corneal hydrops history
- Psychomotor retardation history
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 LinkingTotal fluence adapted to thinnest point pachymetry | Procedure or surgery | Personalized cross linking |
Primary outcome
Keratometry stability
Time frame: Baseline and 6 months
Stability documented by changes in keratometries (measured in diopters) obtained with corneal tomography, as well as uncorrected visual acuity observed in follow up consults
Pachymetry stability
Time frame: Baseline and 6 months
Stability documented by changes in pachymetry (measured in microns) obtained with corneal tomography
Uncorrected visual acuity stability
Time frame: Baseline, 72 hours, 1 week, 3 months and 6 months
Stability documented by changes in uncorrected visual acuity (measured in logarithm of the minimum angle of resolution) obtained on physical examiantion
Corneal endothelium safety
Time frame: Baseline, 72 hours, 1 week, 3 months and 6 months
Corneal endothelial cell count obtained by specular microscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 33340508Hafezi F, Kling S, Gilardoni F, Hafezi N, Hillen M, Abrishamchi R, Gomes JAP, Mazzotta C, Randleman JB, Torres-Netto EA. Individualized Corneal Cross-linking With Riboflavin and UV-A in Ultrathin Corneas: The Sub400 Protocol. Am J Ophthalmol. 2021 Apr;224:133-142. doi: 10.1016/j.ajo.2020.12.011. Epub 2021 Jan 30.
- Background: PubMed 30681515Lang PZ, Hafezi NL, Khandelwal SS, Torres-Netto EA, Hafezi F, Randleman JB. Comparative Functional Outcomes After Corneal Crosslinking Using Standard, Accelerated, and Accelerated With Higher Total Fluence Protocols. Cornea. 2019 Apr;38(4):433-441. doi: 10.1097/ICO.0000000000001878.
- Background: PubMed 33383093Nath S, Shen C, Koziarz A, Banfield L, Nowrouzi-Kia B, Fava MA, Hodge WG. Transepithelial versus Epithelium-off Corneal Collagen Cross-linking for Corneal Ectasia: A Systematic Review and Meta-analysis. Ophthalmology. 2021 Aug;128(8):1150-1160. doi: 10.1016/j.ophtha.2020.12.023. Epub 2020 Dec 28.
- 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.
Enrique Graue, MD, MSc study director
Instituto de Oftalmología Conde de Valenciana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal Cross Linking in people with Keratoconus, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 2 inclusion and 4 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 7 Dec 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 Mexico. 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?
Contact Itamar Vigderovich, MD (+52 5519491905, vigderovich@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratometry stability (time frame: Baseline and 6 months). The study lists 4 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 NCT06159881, which also lists 3 linked publications.
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 7 Dec 2023.