RECRUITING

Functional and Structural Imaging for Glaucoma

Conditions

Glaucoma Optical Coherence Tomography Intraocular pressure Optic nervehead Nerve fiber layer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The specific aims of the clinical studies are to: * Develop a directional high-resolution OCT and OCT angiography prototype to improve imaging of structure and perfusion. * Validate wide-field OCT and OCT angiography parameters to improve early glaucoma detection. * Simulate visual field results by combining structural and angiography OCT data. * Assess abilities of above technologies and OCT-derived parameters on predicting glaucoma detection, conversion, and progression.

Official Title

Longitudinal Observational Study Using Functional and Structural Optical Coherence Tomography to Diagnose and Guide Treatment of Glaucoma

Quick Facts

Study Start:2013-09-25

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01957267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. No history or evidence of retinal pathology or glaucoma 2. Normal Humphrey 24-2 VF: A mean defect (MD), corrected pattern standard deviation (CPSD) within 95% limits of normal reference, and glaucoma hemifield test (GHT) within normal limits (97%). 3. Intraocular pressure \< 21 mm Hg 4. Central corneal pachymetry \> 500 microns 5. No chronic ocular or systemic corticosteroid use 6. Open angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system) 7. Normal appearing ONH and NFL: vertical and horizontal cup/disc ratio (CDR) ≤ 0.5 and intact neuroretinal rim without peripapillary hemorrhages, notches, localized pallor, or NFL defect 8. Symmetric ONH between left and right eyes: CDR difference \< 0.2 in both vertical and horizontal dimensions	1. Best-corrected visual acuity less than 20/40 2. Age \< 40 or \>85 years 3. Refractive error of \> +3.00 D or \< -7.00 D 4. Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation 5. Diabetic retinopathy 6. Other diseases that may cause VF loss or optic disc abnormalities 7. Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil 8. Inability to perform reliably on automated VF testing 9. Life-threatening or debilitating illness making it unlikely patient could successfully complete the study. 10. Refusal of informed consent or of commitment to the full length of the study

Inclusion Criteria

Exclusion Criteria

1. No history or evidence of retinal pathology or glaucoma
2. Normal Humphrey 24-2 VF: A mean defect (MD), corrected pattern standard deviation (CPSD) within 95% limits of normal reference, and glaucoma hemifield test (GHT) within normal limits (97%).
3. Intraocular pressure \< 21 mm Hg
4. Central corneal pachymetry \> 500 microns
5. No chronic ocular or systemic corticosteroid use
6. Open angle (gonioscopy must show 75% or more of the angle to be Grade 2 or more by Shaffer's grading system)
7. Normal appearing ONH and NFL: vertical and horizontal cup/disc ratio (CDR) ≤ 0.5 and intact neuroretinal rim without peripapillary hemorrhages, notches, localized pallor, or NFL defect
8. Symmetric ONH between left and right eyes: CDR difference \< 0.2 in both vertical and horizontal dimensions

1. Best-corrected visual acuity less than 20/40
2. Age \< 40 or \>85 years
3. Refractive error of \> +3.00 D or \< -7.00 D
4. Previous intraocular surgery except for uncomplicated keratorefractive surgery and cataract extraction with posterior chamber intraocular lens implantation
5. Diabetic retinopathy
6. Other diseases that may cause VF loss or optic disc abnormalities
7. Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
8. Inability to perform reliably on automated VF testing
9. Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.
10. Refusal of informed consent or of commitment to the full length of the study

Contacts and Locations

Study Contact

Chinmay Deshpande, M.Optom.

CONTACT

503-494-9628

deshpanc@ohsu.edu

Denzil Romfh, OD

CONTACT

503-494-4351

romfhd@ohsu.edu

Principal Investigator

Aiyin Chen, MD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University, Casey Eye Institute

Portland, Oregon, 97214

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Aiyin Chen, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-09-25

Study Completion Date2026-05

Study Record Updates

Study Start Date2013-09-25

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Glaucoma
Optical Coherence Tomography
Intraocular pressure
Optic nervehead
Nerve fiber layer

Additional Relevant MeSH Terms

Glaucoma