NCT06159881

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

November 28, 2023

Last Update Submit

December 5, 2023

Conditions

Keratoconus

Keywords

ProgressionCustomizedCross-Linking

Outcome Measures

Primary Outcomes (4)

  • 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

    Baseline and 6 months

  • Pachymetry stability

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

    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

    Baseline, 72 hours, 1 week, 3 months and 6 months

  • Corneal endothelium safety

    Corneal endothelial cell count obtained by specular microscopy

    Baseline, 72 hours, 1 week, 3 months and 6 months

Study Arms (1)

Personalized cross linking

EXPERIMENTAL

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

Procedure: Corneal Cross Linking

Interventions

Corneal Cross LinkingPROCEDURE

Total fluence adapted to thinnest point pachymetry

Personalized cross linking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Oftalmología Conde de Valenciana

Mexico City, Mexico

RECRUITING

Related Publications (3)

  • 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.

    PMID: 33340508BACKGROUND

  • 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.

    PMID: 30681515BACKGROUND

  • 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.

    PMID: 33383093BACKGROUND

MeSH Terms

Conditions

KeratoconusDisease Progression

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Enrique Graue, MD, MSc

    Instituto de Oftalmología Conde de Valenciana

    STUDY DIRECTOR

Central Study Contacts

Itamar Vigderovich, MD

CONTACT

+52 5519491905vigderovich@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 7, 2023

Study Start

March 1, 2023

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

December 7, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)