NCT05717517

Brief Summary

  1. 1.Assessment of corneal changes in AS-OCT after collagen cross-linking (corneal thickness and demarcation line).
  2. 2.Assessment of the effect of collagen cross-linking on best-corrected visual acuity

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 19, 2021

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

October 19, 2021

Last Update Submit

July 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • corneal thickness after collagen cross linking OCT study

    corneal thickness measurement in mm

    12 months

Secondary Outcomes (1)

  • corneal demarcation line after collagen cross linking OCT study

    12 months

Interventions

ant segment oct before and after corneal collagen cross-linking

Also known as: collagen cross linking

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent classic corneal collagen cross-linking

You may qualify if:

  • patients with e corneal ectasia who are candidates for CXL.

You may not qualify if:

  • patients with other corneal diseases not treated by collagen cross-linking
  • corneal scarring.
  • previous corneal surgeries (e.g intrastromal corneal ring segments)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Wollensak G, Spoerl E, Seiler T. Stress-strain measurements of human and porcine corneas after riboflavin-ultraviolet-A-induced cross-linking. J Cataract Refract Surg. 2003 Sep;29(9):1780-5. doi: 10.1016/s0886-3350(03)00407-3.

    PMID: 14522301BACKGROUND
  • Raiskup F, Spoerl E. Corneal crosslinking with riboflavin and ultraviolet A. I. Principles. Ocul Surf. 2013 Apr;11(2):65-74. doi: 10.1016/j.jtos.2013.01.002. Epub 2013 Jan 24.

    PMID: 23583042BACKGROUND
  • Brummer G, Littlechild S, McCall S, Zhang Y, Conrad GW. The role of nonenzymatic glycation and carbonyls in collagen cross-linking for the treatment of keratoconus. Invest Ophthalmol Vis Sci. 2011 Aug 11;52(9):6363-9. doi: 10.1167/iovs.11-7585.

    PMID: 21724915BACKGROUND
  • Raiskup F, Terai N, Velika V, Sporl E. [Corneal Cross-Linking with Riboflavin and UVA in Keratoconus]. Klin Monbl Augenheilkd. 2016 Aug;233(8):938-44. doi: 10.1055/s-0042-102060. Epub 2016 Apr 7. German.

    PMID: 27055493BACKGROUND

MeSH Terms

Interventions

Corneal Cross-Linking

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Central Study Contacts

mohammed saad, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

October 19, 2021

First Posted

February 8, 2023

Study Start

August 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

July 19, 2023

Record last verified: 2023-07