NCT05114928

Brief Summary

Keratoconus is a progressive corneal disease characterized by asymmetric corneal thinning and structural changes in corneal collagen which leads to decrease in visual acuity due to myopic shift, irregular astigmatism or corneal scarring. Early detection of the disease in children aids in halting the progression and improve their quality of life. There is no consensus regarding the progression criteria of the disease, we aimed to assess the changes in corneal asphericity in children after corneal collagen crosslinking and investigate any possible correlation with progression criteria widely used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 9, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

October 1, 2021

Enrollment Period

16 days

First QC Date

October 29, 2021

Last Update Submit

October 29, 2021

Conditions

KeratoconusCollagen DiseasesCorneal Disease

Keywords

corneal asphericitycorneal collagen cross-linkingQ-valuePediatric keratoconusTrans-epithelial

Outcome Measures

Primary Outcomes (1)

  • Changes in corneal asphericity (Q-value) in all subjects.

    Evaluate the changes in Q-value after Trans-epithelial corneal collagen cross-linking (TE-CXL) using pentacam.

    Baseline and annually after TE-CXL till 5 years of follow-up

Secondary Outcomes (2)

  • Correlation between Q-value changes and disease progression in both groups.

    Baseline and annually after TE-CXL till 5 years of follow-up

  • The Q-value as a predictive value in keratoconus progression.

    Baseline and annually after TE-CXL till 5 years of follow-up

Study Arms (2)

Progression Group (P-group)

Eyes that showed progression of the disease after trans-epithelial corneal collagen cross-linking during the 5 years of follow-up, (number of eyes = 7 eyes).

Procedure: Transepithelial Corneal Collagen Cross-linkingDiagnostic Test: Scheimpflug camera

No Progression Group (NP-group)

Eyes that showed no progression of the disease after trans-epithelial corneal collagen cross-linking during the 5 years of follow-up, (number of eyes = 11 eyes).

Procedure: Transepithelial Corneal Collagen Cross-linkingDiagnostic Test: Scheimpflug camera

Interventions

Transepithelial Corneal Collagen Cross-linkingPROCEDURE

Bilateral Transepithelial Corneal Collagen Cross-linking was done for all subjects using power of 9mW/cm2 at 55mm from the cornea for 10 minutes, with a total energy of 5.4j/cm2 using the (CCL VARIO, PESCHKE Trade GmbH, Huenenberg Switzerland), in the period between January 2016 to August 2016.

Also known as: TE-CXL
No Progression Group (NP-group)Progression Group (P-group)
Scheimpflug cameraDIAGNOSTIC_TEST

Pentacam (OCULUS Optikgeräte GmbH, Wetzlar, Germany) was done for all subjects at baseline and annually after TE-CXL till 5 years of follow-up.

Also known as: Pentacam
No Progression Group (NP-group)Progression Group (P-group)

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This retrospective observational study was performed at Ophthalmology department, Benha University, EGYPT using the medical records of 9 children diagnosed as bilateral progressive KC that was confirmed by Pentacam according to amsler criteria, patients had undergone bilateral TE-CXL in the period from January 2016 to August 2016 and completed annual visits till 5 years of follow-up.

You may qualify if:

  • Children that were diagnosed as bilateral progressive KC (stage I-III, according to amsler classification, Kmax change \>1D between 2 scanning with at least 2 months apart), and their age were less than 16 years old at time of TE-CXL, topographic parameters were Kmax 47-60D and MCT more than 400μm.

You may not qualify if:

  • Eyes with central corneal scarring, amblyopic eyes, and other corneal pathologies that may alter Pentacam scanning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy Tabl

Banhā, Benha, 13511, Egypt

Location

MeSH Terms

Conditions

KeratoconusCollagen DiseasesCorneal Diseases

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Eye DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Ahmed A Tabl, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 10, 2021

Study Start

October 9, 2021

Primary Completion

October 25, 2021

Study Completion

October 28, 2021

Last Updated

November 10, 2021

Record last verified: 2021-10

Locations

EG(1)