GlaucomaNCT02604953
Comparing SD-tVEP and PERG Tests Between Patients With Glaucoma, Patients With High Eye Pressure and "Normal" Patients
An observational study of Glaucoma, run by Wills Eye.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Short Duration Transient Visual Evoked Potential (SDtVEP) and Pattern electroretinogram (PERG)
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ocular hypertension, glaucoma patients and healthy controls with no eye diseases.
Who may be able to join
- Inclusion Criteria for ocular hypertension patients (Group A):
- 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%)
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- 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.
Who cannot join
- 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.
About this study
Official title: 1-Year Prospective Study: SD-tVEP and PERG for Early Detection of Retinal Ganglion Cell Dysfunction in Ocular Hypertension Patients
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.
Read the detailed description
Glaucoma is the most common cause of irreversible blindness worldwide. It is characterized by the progressive loss of retinal ganglion cells (RGCs) and a corresponding loss of vision. Elevated intraocular pressure (IOP) is an important risk factor for glaucoma, but its role in the diagnosis of glaucoma is unclear. Although IOP-lowering therapy delays the onset of glaucoma in some patients with ocular hypertension, even without therapy, 90% of patients will not develop glaucoma over a 5-year period.
Visual evoked potentials (VEPs) are able to detect the disruption of electrical signals at any point along the visual pathway, from the RGCs to the primary visual cortex. As an objective measure of visual function, the VEP may have an advantage over traditional visual field tests, by reducing confounded factors such as age, fatigue, and mental status.
There is a growing body of evidence that SD-tVEP can objectively identify early visual dysfunction due to glaucoma.
Aim 1: Compare the results of the baseline SD-tVEP and PERG vision testing in patients with ocular hypertension to a cohort of 30 healthy subjects and a cohort of 30 patients with glaucoma (of varying severity) to determine its ability to detect visual dysfunction in ocular hypertensive subjects.
Aim 2: Conduct SD-tVEP and PERG testing system in 30 patients with ocular hypertension before and after IOP reduction with topical medication and compare the results of the SD-tVEP and PERG before and after treatment in each patient, to determine its ability to detect reversible RGC dysfunction.
- Conditions
- Glaucoma
- Being tested
- Short Duration Transient Visual Evoked Potential (SDtVEP), Pattern electroretinogram (PERG)
- Keywords
- glaucoma, VEP, PERG, SD-tVEP, ss-PERG
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Duration Transient Visual Evoked Potential (SDtVEP)Diagnostic test
Also called SDtVEP
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.
Pattern electroretinogram (PERG)Diagnostic test
Also called PERG
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP); Diagnostic Test: Pattern electroretinogram (PERG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Mantravadi, Wills Eye
- Investigators
- Anand Mantravadi, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604953
- Sponsor's protocol ID
- 13-358
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2015
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data has been presented at the American Glaucoma Society in March 2015 and manuscript will be submitted for publication in 2017.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-Year Prospective Study: SD-tVEP and PERG for Early Detection of Retinal Ganglion Cell Dysfunction in Ocular Hypertension Patients
- ClinicalTrials.gov ID
- NCT02604953
- Acronym / sponsor ID
- 13-358
- Conditions
- Glaucoma
- Keywords
- glaucoma, VEP, PERG, SD-tVEP, ss-PERG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glaucoma is the most common cause of irreversible blindness worldwide. It is characterized by the progressive loss of retinal ganglion cells (RGCs) and a corresponding loss of vision. Elevated intraocular pressure (IOP) is an important risk factor for glaucoma, but its role in the diagnosis of glaucoma is unclear. Although IOP-lowering therapy delays the onset of glaucoma in some patients with ocular hypertension, even without therapy, 90% of patients will not develop glaucoma over a 5-year period.
Visual evoked potentials (VEPs) are able to detect the disruption of electrical signals at any point along the visual pathway, from the RGCs to the primary visual cortex. As an objective measure of visual function, the VEP may have an advantage over traditional visual field tests, by reducing confounded factors such as age, fatigue, and mental status.
There is a growing body of evidence that SD-tVEP can objectively identify early visual dysfunction due to glaucoma.
Aim 1: Compare the results of the baseline SD-tVEP and PERG vision testing in patients with ocular hypertension to a cohort of 30 healthy subjects and a cohort of 30 patients with glaucoma (of varying severity) to determine its ability to detect visual dysfunction in ocular hypertensive subjects.
Aim 2: Conduct SD-tVEP and PERG testing system in 30 patients with ocular hypertension before and after IOP reduction with topical medication and compare the results of the SD-tVEP and PERG before and after treatment in each patient, to determine its ability to detect reversible RGC dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ocular Hypertension patients | – | Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP), Diagnostic Test: Pattern electroretinogram (PERG)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. |
| Healthy Controls | – | Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP), Diagnostic Test: Pattern electroretinogram (PERG)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. |
| Glaucoma patients | – | Diagnostic Test: Short Duration Transient Visual Evoked Potential (SDtVEP), Diagnostic Test: Pattern electroretinogram (PERG)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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ocular hypertension, glaucoma patients and healthy controls with no eye diseases.
Key inclusion criteria (15 listed)
- 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%)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Duration Transient Visual Evoked Potential (SDtVEP)Also: SDtVEPShort 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. | Diagnostic test | Glaucoma patients, Healthy Controls, Ocular Hypertension patients |
| Pattern electroretinogram (PERG)Also: PERGPattern 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. | Diagnostic test | Glaucoma patients, Healthy Controls, Ocular Hypertension patients |
Primary outcome
Short Duration Transient Visual Evoked Potential (SD- tVEP)
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No. Data has been presented at the American Glaucoma Society in March 2015 and manuscript will be submitted for publication in 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Mantravadi, MD principal investigator
Wills Eye Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Wills Eye.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Duration Transient Visual Evoked Potential (SD- tVEP) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.