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Completed

NCT Number: NCT05114928

Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.

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.

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Key information

Conditions

Keratoconus Collagen Diseases Connective Tissue Diseases Corneal Disease Corneal Diseases Eye Diseases Skin and Connective Tissue Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmed Abdelshafy Tabl

Banhā, Benha, 13511, Egypt

About this study

The Keratoconus progression is defined as increasing by 1.0 diopter (D) or more in the maximum keratometry (Kmax), progressive deterioration in Minimal Corneal Thickness is also associated with KC progression, other methods have been investigated to confirm KC progression such as changes in manifest refraction, unaided visual acuity (UAVA), BCVA, posterior keratometric data and higher order aberrations (HOA) which are altered in KC and can aid to confirm disease progression. Q-value (a coefficient of corneal asphericity) reflects the shape of the cornea, its refractive power, and spherical aberration. The mean Q-value in normal cornea is -0.26 ± 0.18, the severity of KC and the Q-value are inversely related.

Mean Q-value in KC at 8mm zone is -0.84 and -1.10 for anterior and posterior corneal surfaces, respectively. Until now, no precise criteria of KC progression especially in cases had undergone previous trans-epithelial corneal collagen cross-linking (TE-CXL) to halt the progression of the disease. In the present study we aimed to analyze the correlation between the changes in Q-value and progression of the KC in children had undergone bilateral TE-CXL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Transepithelial Corneal Collagen Cross-linking

Procedure

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.

Other names: TE-CXL

Scheimpflug camera

Diagnostic 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.

Other names: Pentacam

Primary outcomes

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

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

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

Secondary outcomes

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

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

    Correlation between the changes in Q-value in different corneal zones and maximum keratometry and minimal corneal thickness in both groups over 5 years of follow-up.

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

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

    The possibility of using the Q-value parameters as a predictive values to confirm keratoconus progression in children.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Correlation Between Changes in Corneal Asphericity and Progression of Keratoconus in Children

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2021
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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