Anterior Corneal Striae in Hypotony

May 2, 2020 updated by: Duke University

The Clinical Significance of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects >= 18 years of age with a history of glaucoma and glaucoma surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anterior Cornea Striae
Eyes with anterior cornea striae present
Other: Ophthalmic imaging
Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos
Hypotony Maculopathy
Eyes with hypotony maculopathy present
Other: Ophthalmic imaging
Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos
Hypotony only
Eyes with intraocular pressure less than 10 without cornea striae and/or maculopathy
Other: Ophthalmic imaging
Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal hysteresis
Time Frame: Baseline
Difference in postoperative corneal hysteresis (measured in mm Hg) by Ocular Response Analyzer, between study arms
Baseline
Incidence of anterior corneal striae
Time Frame: Baseline
Frequency of occurrence among all enrolled hypotonous eyes
Baseline
Incidence of hypotony maculopathy
Time Frame: Baseline
Frequency of occurrence among all enrolled hypotonous eyes
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length
Time Frame: Baseline
Difference in postoperative axial length between study arms
Baseline
Corneal thickness
Time Frame: Baseline
Difference in postoperative corneal thickness between study arms
Baseline
Corneal curvature
Time Frame: Baseline
Difference in postoperative diopters of steepest cornea axis, flattest cornea axis and astigmatism between study arms
Baseline
Corneal resistance factor
Time Frame: Baseline
Difference in postoperative corneal resistance factor between study arms
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Leon Herndon, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 17, 2019

Primary Completion (ACTUAL)

March 23, 2020

Study Completion (ACTUAL)

March 23, 2020

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (ACTUAL)

July 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 2, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00102744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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