Anterior Corneal Striae in Hypotony

Maculopathy Clinical Trial

Official title:

The Clinical Significance of Anterior Corneal Striae in Hypotony

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023123
• Other study ID #: Pro00102744
• Status: Completed
• Start date: September 17, 2019
• Est. completion date: March 23, 2020

Study information

• Verified date: June 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cornea Folds and Rupture of Bowman's Membrane Both Eyes
• Hypotony Ocular
• Maculopathy
• Rupture

Intervention

Other:
• Ophthalmic imaging
Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal hysteresis	Difference in postoperative corneal hysteresis (measured in mm Hg) by Ocular Response Analyzer, between study arms	Baseline
Primary	Incidence of anterior corneal striae	Frequency of occurrence among all enrolled hypotonous eyes	Baseline
Primary	Incidence of hypotony maculopathy	Frequency of occurrence among all enrolled hypotonous eyes	Baseline
Secondary	Axial length	Difference in postoperative axial length between study arms	Baseline
Secondary	Corneal thickness	Difference in postoperative corneal thickness between study arms	Baseline
Secondary	Corneal curvature	Difference in postoperative diopters of steepest cornea axis, flattest cornea axis and astigmatism between study arms	Baseline
Secondary	Corneal resistance factor	Difference in postoperative corneal resistance factor between study arms	Baseline