The Characteristics of Backscattering With Depth in the Progression of Keratoconus

Completed

• Conditions: Elasticum, Incomplete Pseudoxanthoma

• Registration Number: NCT06050629
• Lead Sponsor: Tianjin Eye Hospital

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-30
• Status Verified: 2023-09
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

1. BCVA <20/20 and a history of myopia or astigmatism;
2. 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;
3. 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

1. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
backscattering	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).

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China