The Characteristics of Backscattering With Depth in the Progression of Keratoconus

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus

NCT02617368

Keratoconus

COMPLETED

Corneal Biomechanical Properties and Anterior Segment Parameters, in Forme Fruste Keratoconus

NCT01448408

Keratoconus Forme Fruste Keratoconus

COMPLETED

Astigmatic Vector Analysis of Posterior Cornea - a Comparison Among Healthy, Forme Fruste and Overt Keratoconus Corneas

NCT02698709

Keratoconus

COMPLETED

Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus

NCT02189447

Keratoconus

COMPLETED NA

Retrospective Observational Study of Posterior Keratometry Measured

NCT04422080

Keratoconus

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elasticum, Incomplete Pseudoxanthoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

forme fruste keratoconus

1\) no other eye abnormalities except myopia and astigmatism; 2) transparent cornea; 3) no positive signs of keratoconus on slit lamp examination or morphology examination (excluding the appearance of keratoconus as described above, and simultaneously satisfying A0B0C0D0, Index of Surface variance (ISV) \< 30, and Keratoconus Index (KI) \< 1.07); and 4) Belin/Ambrósio enhanced ectasia total derivation value(BAD-D)≤1.6

No interventions assigned to this group

Clinical keratoconus

46.5 D ≤ Mean K \<52 D; 55≤ ISV\<200; and 1.10 ≤ KI \<1.50

No interventions assigned to this group

severe keratoconus

Mean K ≥ 52D; ISV≥ 200; and KI≥ 1.50

No interventions assigned to this group

normal eye

one eye of healthy participants before refractive surgery were randomly selected. Comprehensive ophthalmic examinations were performed before surgery, which confirmed that the cornea was clear and normal in shape. For this group, there was no family history of keratoconus, no other diseases except ametropia, and no corneal dilatation one year after surgery.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes