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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159881
• Other study ID #: 17 CI 09 015 008
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: December 2023
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: Itamar Vigderovich, MD
• Phone: +52 5519491905
• Email: vigderovich[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Keratoconus diagnosed with corneal tomography/topography

• Thinnest point pachymetry below 400 microns

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Corneal Cross Linking
Total fluence adapted to thinnest point pachymetry

Locations

Country	Name	City	State
Mexico	Instituto de Oftalmología Conde de Valenciana	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pachymetry stability	Stability documented by changes in pachymetry (measured in microns) obtained with corneal tomography	Baseline and 6 months
Primary	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
Primary	Corneal endothelium safety	Corneal endothelial cell count obtained by specular microscopy	Baseline, 72 hours, 1 week, 3 months and 6 months