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Functional and Structural Imaging for Glaucoma

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests OCT eye scans, which show eye tissue and blood flow, to help find glaucoma early and predict if it will develop or get worse. Glaucoma is an eye disease that damages the nerve used for sight. The study is for adults ages 40 to 85 with healthy eyes or glaucoma.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Healthy-eye group: Both eyes must meet all healthy-eye rules below.
  • Healthy-eye group: No signs or history of glaucoma or disease of the retina, the light-sensing layer at the back of the eye.
  • Healthy-eye group: Normal results on the required side-vision test.
  • Healthy-eye group: Eye pressure below 21 mm Hg and cornea thickness above 500 microns. The cornea is the clear front of the eye.
  • Healthy-eye group: No long-term use of steroid medicines for the eyes or body.
  • Healthy-eye group: The eye's drainage angle must be open and meet the study's exam limits.
  • Healthy-eye group: The nerve used for sight and its fibers must look normal and similar in both eyes, within the study's measurement limits.
  • Glaucoma group: An eye exam must show specified damage to the nerve used for sight or its fibers, such as thinning, bleeding, or a notch. Side-vision loss is not required.

Who can't join

  • Younger than 40 or older than 85.
  • Vision worse than 20/40 with the best glasses or contacts, or an eye prescription above +3.00 or below -7.00 diopters.
  • Past surgery inside the eye, except uncomplicated vision-correction surgery or cataract surgery with a lens placed behind the iris.
  • Eye damage from diabetes, or another disease that can cause side-vision loss or changes to the nerve used for sight.
  • Cloudiness in the eye or a pupil that does not open wide enough to view or photograph the nerve.
  • Unable to give reliable results on the machine-based side-vision test.
  • A life-threatening or disabling illness that makes finishing the study unlikely.
  • Not willing to give informed consent or commit to the full study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Normal Subjects (both eyes must meet all 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 Inclusion criteria: Glaucoma Group 1. ONH or NFL defect visible on slit-lamp biomicroscopy defined as one of following: 1. diffuse or localized thinning of the rim 2. disc (splinter) hemorrhage 3. notch in the rim 4. vertical cup/disc ratio greater than the fellow eye by \> 0.2 2. Presence or absence of VF defects as measured by Humphrey SITA 24-2 VF. Exclusion Criteria: All Groups 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

Study sites (1)

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