Anterior Corneal Striae in Hypotony

Completed

• Conditions: Hypotony Ocular; Cornea Folds and Rupture of Bowman's Membrane Both Eyes; Maculopathy
• Interventions: Other: Ophthalmic imaging

• Registration Number: NCT04023123
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-17
• Study Start: 2019-09-17
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-23
• Last Update Submitted: 2020-05-02
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anterior Cornea Striae	Ophthalmic imaging	Eyes with anterior cornea striae present
Hypotony Maculopathy	Ophthalmic imaging	Eyes with hypotony maculopathy present
Hypotony only	Ophthalmic imaging	Eyes with intraocular pressure less than 10 without cornea striae and/or maculopathy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Axial length	Baseline	Difference in postoperative axial length between study arms
Corneal thickness	Baseline	Difference in postoperative corneal thickness between study arms
Corneal curvature	Baseline	Difference in postoperative diopters of steepest cornea axis, flattest cornea axis and astigmatism between study arms
Corneal resistance factor	Baseline	Difference in postoperative corneal resistance factor between study arms

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States