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Completed

NCT Number: NCT06050629

The Characteristics of Backscattering With Depth in the Progression of Keratoconus

To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC.

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Key information

Conditions

Elasticum, Incomplete Pseudoxanthoma Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Pseudoxanthoma Elasticum Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

About this study

To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC. A Scheimpflug corneal tomography image and caliper tool were used to obtain backscatter at every 2% depth at the thinnest point of the cornea, with the measured values expressed in grayscale units (GSU).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BCVA <20/20 and a history of myopia or astigmatism;
  • presence of any of the following positive signs on slit lamp examination: corneal stromal thinning, cone-shaped anterior protrusions, Fleischer's ring, Vogt's striae, epithelial or subepithelial scarring;
  • abnormal corneal topography (maximum keratometry (K) value of >47.2 diopters (D), bow-tie pattern with skewed radial axes, or inferior-superior asymmetry(3-mm I-S keratometric difference >1.4 D).

Exclusion criteria

  • Patients with severe corneal scarring that affected light scattering and density maps showing "black holes" 2.Participatients with other corneal diseases 3. Eyes that have undergone surgery or trauma 4. Eyes with corneal dystrophy

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Treatment and study plan

Primary outcomes

  1. backscattering

    Time frame: through study completion, an average of 1 year

    Standard measurements were performed using a Pentacam (Pentacam HR; Oculus, Wetzlar, Germany);The average brightness of a predetermined area of the cornea was calculated, shown as densitometry, and recorded in GSU ranging from 0 to 100 (0, cornea is transparent without opacity; 100, cornea is completely opaque).

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Official study title

The Characteristics of Backscattering With Depth in the Progression of Keratoconus and Its Role in Forme Fruste Keratoconus Detection

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2023
Registry last updated
Sep 22, 2023

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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