Anterior Corneal Striae in Hypotony
The Clinical Significance of Anterior Corneal Striae in Hypotony
1 other identifier
observational
98
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2019
CompletedFirst Posted
Study publicly available on registry
July 17, 2019
CompletedStudy Start
First participant enrolled
September 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2020
CompletedMay 5, 2020
June 1, 2019
6 months
July 11, 2019
May 2, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Corneal hysteresis
Difference in postoperative corneal hysteresis (measured in mm Hg) by Ocular Response Analyzer, between study arms
Baseline
Incidence of anterior corneal striae
Frequency of occurrence among all enrolled hypotonous eyes
Baseline
Incidence of hypotony maculopathy
Frequency of occurrence among all enrolled hypotonous eyes
Baseline
Secondary Outcomes (4)
Axial length
Baseline
Corneal thickness
Baseline
Corneal curvature
Baseline
Corneal resistance factor
Baseline
Study Arms (3)
Anterior Cornea Striae
Eyes with anterior cornea striae present
Hypotony Maculopathy
Eyes with hypotony maculopathy present
Hypotony only
Eyes with intraocular pressure less than 10 without cornea striae and/or maculopathy
Interventions
Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos
Eligibility Criteria
Subjects \>= 18 years of age with a history of glaucoma and glaucoma surgery
You may qualify if:
- 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
You may not qualify if:
- Coexisting ocular disease that may affect ocular biomechanics, including macular disease, corneal transplant, and uveitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Health System
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leon Herndon, MD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2019
First Posted
July 17, 2019
Study Start
September 17, 2019
Primary Completion
March 23, 2020
Study Completion
March 23, 2020
Last Updated
May 5, 2020
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share