Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus

Not Applicable

Recruiting

• Conditions: Keratoconus; Glaucoma
• Interventions: Device: Ophthalmodynamometer; Device: Goldmann applanation tonometer; Device: Pentacam; Device: ORA; Device: Optical Coherence Tomography (OCT)

• Registration Number: NCT03560609
• Lead Sponsor: NYU Langone Health

Brief Summary

The mechanism by which vision loss in glaucoma occurs is still unknown, but it is clear that increased Intraocular Pressure (IOP) is a major risk factor. It is also thought that the lamina cribrosa (LC) is a site of primary damage during the pathogenesis of the disease. The changes caused by intraocular pressure (IOP) modulation at the level of the optic nerve head and LC will be evaluated in the present study. Subjects with keratoconus exhibit abnormal collagen properties that can impair their LC behavior. By evaluating their lamina biomechanical response we can advance our understanding on the role of the lamina in glaucoma pathogenesis. A better understanding of the process will ultimately lead to improved detection and management of glaucoma.

It is hypothesized that subjects with keratoconus have an abnormal biomechanical response of the lamina cribrosa in response to IOP modulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-18
• Study Start: 2018-11-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Candidates must meet the following inclusion criteria in order to participate in the study.

• Ability to provide informed consent and to understand the study procedures

Keratoconus:

• Clinical diagnosis of keratoconus
• Central thinning of the cornea
• Abnormal posterior ectasia.

Glaucoma:

• Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
• Two consecutive abnormal SITA standard perimetry tests with GHT outside normal limits.

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Exclusion Criteria

Candidates that meet any of the exclusion criteria at baseline will be excluded from study participation.

• Media opacity (e.g. lens, vitreous, cornea).
• Strabismus, nystagmus or a condition that would prevent fixation.
• Diabetes with evidence of retinopathy.
• Previous intraocular surgery or ocular trauma (with the exception of laser procedures and subjects that have undergone uneventful cataract surgery more than 6 months from enrollment date).
• Neurological and non-glaucomatous causes for visual field damage.
• Any intraocular non-glaucomatous ocular disorders.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects With Keratoconus	Goldmann applanation tonometer	-
Subjects With Keratoconus	Ophthalmodynamometer	-
Subjects With Keratoconus	Pentacam	-
Subjects with Glaucoma	Pentacam	-
Subjects with Glaucoma	Optical Coherence Tomography (OCT)	-
Subjects With Keratoconus	ORA	-
Subjects With Keratoconus	Optical Coherence Tomography (OCT)	-
Subjects with Glaucoma	Goldmann applanation tonometer	-
Subjects with Glaucoma	Ophthalmodynamometer	-
Subjects with Glaucoma	ORA	-

Primary Outcome Measures

Name	Time	Method
LC measurements measured in microns	1 Day	These micron measurements will be obtained from in vivio OCT images
Anterior laminar displacement measured in microns	1 Day	These micron measurements will be obtained from in vivio OCT images

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States