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

NCT ID: NCT05114928

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-09

Study Completion Date

2021-10-28

Brief Summary

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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

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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

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Keratoconus Collagen Diseases Corneal Disease

Keywords

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corneal asphericity corneal collagen cross-linking Q-value Pediatric keratoconus Trans-epithelial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Transepithelial Corneal Collagen Cross-linking

Intervention Type 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.

Scheimpflug camera

Intervention Type 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.

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).

Transepithelial Corneal Collagen Cross-linking

Intervention Type 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.

Scheimpflug camera

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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TE-CXL Pentacam

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelshafy

Lecturer of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed A Tabl, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

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Ahmed Abdelshafy Tabl

Banhā, Benha, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC-10-7-01

Identifier Type: -

Identifier Source: org_study_id