NCT05114928

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Keratoconus
• Collagen Diseases
• Corneal Disease

Interventions

Type	Name	Description
PROCEDURE	Transepithelial Corneal Collagen Cross-linking	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.
DIAGNOSTIC_TEST	Scheimpflug camera	Pentacam (OCULUS Optikgeräte GmbH, Wetzlar, Germany) was done for all subjects at baseline and annually after TE-CXL till 5 years of follow-up.

Timeline

• Start date: 2021-10-09
• Primary completion: 2021-10-25
• Completion: 2021-10-28
• First posted: 2021-11-10
• Last updated: 2021-11-10

Locations

1 site across 1 country: Egypt