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NCT Number: NCT06905977

Thick Cornea with High Back Elevation

To follow up cases of thick cornea with high back elevation by pentacam.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The cornea plays a crucial role in refraction and so help in good visual acuity. with its thickness and back elevation being essential parameters in diagnosing and managing corneal diseases such as keratoconus.

The normal human cornea has a central thickness of approximately 540-550 µm. The periphery is generally thicker, reaching up to 700 µm. Corneal thickness is influenced by genetics, hydration, and intraocular pressure.Thick Cornea (> 540 µm): Seen in conditions such as corneal edema and Fuchs' dystrophy. Thin Cornea (< 500 µm): Observed in keratoconus, LASIK-induced thinning, and corneal ectasia.

Back corneal elevation is assessed using corneal topography or tomography, typically referenced to a best-fit sphere (BFS). In normal cases, Back corneal elevation is usually ≤12 µm above the BFS, indicating a structurally healthy cornea without signs of ectasia. Susceptible elevation ranges between 12-20 µm, which may be an early indicator of corneal instability, such as subclinical keratoconus. Therefore, it should be evaluated alongside other parameters, including pachymetry, anterior curvature, and biomechanical properties. Abnormal back corneal elevation is generally considered >20 µm, particularly if localized or asymmetric, and is strongly associated with corneal ectatic disorders such as keratoconus, pellucid marginal degeneration, or post-LASIK ectasia. This abnormal elevation is often accompanied by other risk factors, including increased posterior corneal curvature, corneal thinning, and significant asymmetry, necessitating further assessment and monitoring.

Many cases of thick cornea are associated with high back elevation and this discourage refractive surgery in such cases so in investigator's study the investigator will follow up these cases to determine if these corneas are considered normal corneas or not.

Who can participate

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

Inclusion criteria

Any patient can interact with pentacam. Both Genders: include both males and females. Patients with thick cornea (>540 µm) with high back elevation.

Exclusion criteria

  • Patients with any eye disease (significant cataract or unstable glaucoma)
  • Uncontrolled external disease such as blepharitis , moderate to severe dry eye and allergy.
  • Patient with ocular disease such as uveitis, post herpetic infection and corneal opacity

Treatment and study plan

pentacam

Device

we will follow up on cases of thick cornea with high back elevation

Primary outcomes

  1. Measurement of corneal thickness and back corneal elevation by pentacam device

    Time frame: Baseline

    The investigator will image the cornea to measure corneal thickness and back corneal elevation using the Pentacam device and follow up for cases of thick corneas with high back elevation at 3 months, 6 months, and 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Fathalla, Professor

CONTACT

[email protected]

01223971401

Merna Fily

CONTACT

[email protected]

01226081248

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Long Term Follow-up Study on Thick Cornea with High Back Elevation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

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.