ClinicalTrials.gg
RecruitingNCT06159881Updated Dec 7, 2023

Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus

An interventional study of Corneal Cross Linking in Keratoconus, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 8 months after the study started (first participant enrolled Mar 2023, registered Nov 2023).
  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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? Participants will be treated with personalized energy corneal cross linking and posteriorly, will attend subsequent follow-up consults
02

Conditions studied

  • Keratoconus

Keywords

  • Progression
  • Customized
  • Cross-Linking
03

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 205 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Keratoconus diagnosed with corneal tomography/topography
  • Thinnest point pachymetry below 400 microns

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Personalized cross linking

    Participants were treated with personalized energy cross linking according to their thinnest point corneal pachymetry

    Procedure: Corneal Cross Linking

Interventions

  • ProcedureCorneal Cross Linking

    Total fluence adapted to thinnest point pachymetry

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and 6 months

  2. Pachymetry stability

    Stability documented by changes in pachymetry (measured in microns) obtained with corneal tomography

    Time frame: Baseline and 6 months

  3. 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

    Time frame: Baseline, 72 hours, 1 week, 3 months and 6 months

  4. Corneal endothelium safety

    Corneal endothelial cell count obtained by specular microscopy

    Time frame: Baseline, 72 hours, 1 week, 3 months and 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 33340508 ↗
  • Lang 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 30681515 ↗
  • Nath 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for May 2024, 14 months after the start.

Of 59 non-industry interventional studies with no phase under Keratoconus, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 14 months is below that.

Counting every sponsor, half of 68 studies reached it within 34 months; a quarter within 12 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2023
First posted
Dec 7, 2023
StartActual
Mar 1, 2023
Primary completionEst.
May 15, 2024
CompletionEst.
May 15, 2024
Last update
Dec 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06159881
Lead sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Responsible party
Sponsor
First posted
Dec 7, 2023
Start date
Mar 1, 2023
Primary completion
May 15, 2024 (estimated)
Completion
May 15, 2024 (estimated)
Last update
Dec 7, 2023

Study contacts

Itamar Vigderovich, MD
Contact
vigderovich@gmail.com
+52 5519491905
Enrique Graue, MD, MSc
study director · Instituto de Oftalmología Conde de Valenciana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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