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OpenTrials
Completed

NCT Number: NCT04023123

Anterior Corneal Striae in Hypotony

The goal of this is to evaluate the biomechanical properties of hypotonous eyes with vertical anterior corneal striae and/or hypotony maculopathy compared to hypotonous eyes without striae.

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Key information

Conditions

Hypotony Ocular Cornea Folds and Rupture of Bowman's Membrane Both Eyes Eye Diseases Macular Degeneration Maculopathy Ocular Hypotension Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects >= 18 years of age
  • History of glaucoma
  • History of glaucoma surgery
  • Intraocular pressure of equal to or less than 10 mm Hg by goldmann applanation

Exclusion criteria

  • Coexisting ocular disease that may affect ocular biomechanics, including macular disease, corneal transplant, and uveitis

Treatment and study plan

Ophthalmic imaging

Other

Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos

Primary outcomes

  1. Corneal hysteresis

    Time frame: Baseline

    Difference in postoperative corneal hysteresis (measured in mm Hg) by Ocular Response Analyzer, between study arms

  2. Incidence of anterior corneal striae

    Time frame: Baseline

    Frequency of occurrence among all enrolled hypotonous eyes

  3. Incidence of hypotony maculopathy

    Time frame: Baseline

    Frequency of occurrence among all enrolled hypotonous eyes

Secondary outcomes

  1. Axial length

    Time frame: Baseline

    Difference in postoperative axial length between study arms

  2. Corneal thickness

    Time frame: Baseline

    Difference in postoperative corneal thickness between study arms

  3. Corneal curvature

    Time frame: Baseline

    Difference in postoperative diopters of steepest cornea axis, flattest cornea axis and astigmatism between study arms

  4. Corneal resistance factor

    Time frame: Baseline

    Difference in postoperative corneal resistance factor between study arms

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

The Clinical Significance of Anterior Corneal Striae in Hypotony

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2019
Registry last updated
May 5, 2020

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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