Anterior Corneal Striae in Hypotony

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04023123
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 15.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypotony Ocular; Cornea Folds and Rupture of Bowman's Membrane Both Eyes; Maculopathy	Other: Ophthalmic imaging

Study Design

• Study Type: Observational
• Actual Enrollment: 98 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Clinical Significance of Anterior Corneal Striae in Hypotony
• Actual Study Start Date: Sep 17, 2019
• Actual Primary Completion Date: Mar 23, 2020
• Actual Study Completion Date: Mar 23, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Corneal hysteresis [Baseline]

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

2. Incidence of anterior corneal striae [Baseline]

   Frequency of occurrence among all enrolled hypotonous eyes

3. Incidence of hypotony maculopathy [Baseline]

   Frequency of occurrence among all enrolled hypotonous eyes

Secondary Outcome Measures

1. Axial length [Baseline]

   Difference in postoperative axial length between study arms

2. Corneal thickness [Baseline]

   Difference in postoperative corneal thickness between study arms

3. Corneal curvature [Baseline]

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

4. Corneal resistance factor [Baseline]

   Difference in postoperative corneal resistance factor between study arms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Health System	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Leon Herndon, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04023123
• Other Study ID Numbers: Pro00102744
• First Posted: Jul 17, 2019
• Last Update Posted: May 5, 2020
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration; Rupture

Study Results

No Results Posted as of May 5, 2020