Comparing SD-tVEP and PERG Tests Between Patients With Glaucoma, Patients With High Eye Pressure and "Normal" Patients

NCT02604953 | Completed

• 1 other identifier: 13-358
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Wills Eye Hospital Glaucoma Research Center will conduct a 1-year prospective study to assess the ability of a Short Duration Transient Visual Evoked Potential (SD- tVEP) and a Steady-State Pattern electro-retinogram (PERG) vision testing system to detect visual dysfunction in patients with ocular hypertension. The study aims to assess the reversibility of retinal ganglion cell (RGC) dysfunction after administering intraocular pressure (IOP) lowering treatment. The investigators hypothesize that SD-tVEP and PERG testing will help develop better treatment for glaucoma patients by increasing understanding of the physiological relationship of IOP and RGC in glaucomatous injury.

Conditions

Glaucoma

Keywords

glaucoma; VEP; PERG; SD-tVEP; ss-PERG

Outcome Measures

Primary Outcomes (1)

• Short Duration Transient Visual Evoked Potential (SD- tVEP)

  Short Duration Transient Visual Evoked Potential (VEP) to objectively measure the functional responses of the entire visual pathway from the anterior segment of the eye to the visual cortex.

  1 day

Study Arms (3)

Ocular Hypertension patients

Ocular hypertension patients are recruited from the Wills Eye Hospital Glaucoma Service. Short Duration Transient Visual Evoked Potential (SD- tVEP) and Pattern electroretinogram (PERG) testing will be conducted.

Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP); Diagnostic Test: Pattern electroretinogram (PERG)

Healthy Controls

Healthy adults are recruited from staff, family and friends of Wills Eye Hospital Glaucoma Research Center. Short Duration Transient Visual Evoked Potential (SD- tVEP) and Pattern electroretinogram (PERG) testing will be conducted.

Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP); Diagnostic Test: Pattern electroretinogram (PERG)

Glaucoma patients

Glaucoma patients are recruited from the Wills Eye Hospital Glaucoma Service. Short Duration Transient Visual Evoked Potential (SD- tVEP) and Pattern electroretinogram (PERG) testing will be conducted.

Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP); Diagnostic Test: Pattern electroretinogram (PERG)

Interventions

Short Duration Transient Visual Evoked Potential (SDtVEP) DIAGNOSTIC_TEST

Short duration transient visual evoked potentials (VEPs) detect disruption of electrical signals at any point along the visual pathway, from the retinal ganglion cells (RGCs) to the primary visual cortex. As an objective measure of visual function, VEP may have advantage over traditional visual field tests, by reducing confounded factors such as age, fatigue, and mental status.

Also known as: SDtVEP

Glaucoma patients; Healthy Controls; Ocular Hypertension patients

Pattern electroretinogram (PERG) DIAGNOSTIC_TEST

Pattern electroretinogram (PERG), an objective test, is used for evaluating early damage to retinal ganglion cells (RGC). In PERG, retinal response is recorded while patterns are viewed in the visual field on a computer monitor.

Also known as: PERG

Glaucoma patients; Healthy Controls; Ocular Hypertension patients

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ocular hypertension, glaucoma patients and healthy controls with no eye diseases.

You may qualify if:

• Patients diagnosed with ocular hypertension as per the ICD-9 code for ocular hypertension (365.04)
• Age between 21 - 80 years
• IOP more than 21 mm hg in both the eyes.
• Open angles on Gonioscopy
• At least 2 normal and reliable visual fields (Humphrey MD \>-2 or Octopus MD ≤0.8; fixation losses, false-positive rate, and false-negative rate each \< 33%)
• Normal optic disks, without any of the following signs: rim notches, peripapillary splinter hemorrhages, or C/D asymmetry \>0.2 between the two eyes
• BCVA ≥ 20/40, Clear media, Pupil diameter \> 3 mm and symmetric
• Spherical refraction within + 5.0 D and cylinder correction within + 3.0 D.
• Patients diagnosed with mild, moderate or severe open angle glaucoma as per the (365.xx)
• Age between 21 - 80 years.
• Patients who attend regular follow-up.
• Individuals with no ocular hypertension or any type of glaucoma.
• Available to participate in the study during the required time frame.
• Age 21-80 years.

You may not qualify if:

• Incisional eye surgery within the past three months.
• Neurological or musculoskeletal problems that would influence performance on activities of daily living.
• Laser therapy within the previous month.
• Any cause for visual reduction (greater than 20/40 VA) other than glaucoma.
• Any medical condition which in the investigator's opinion would preclude the subject from providing reliable and valid data.
• History of hypersensitivity to Bimatoprost and Brimonidine, or currently taking an MAO inhibitor
• Currently taking any IOP lowering therapies.

Sponsors & Collaborators

• Wills Eye: lead

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Anand Mantravadi, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 16, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share