CLAD Deconvolved PERG Responses in Glaucoma Patients
1 other identifier
interventional
120
1 country
1
Brief Summary
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMay 16, 2024
May 1, 2024
2 years
April 22, 2024
May 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PERG Amplitude
Response amplitude measured in microvolts
Immediately after measurement
PERG Latency
Response feature latency in milliseconds following the stimulus delivery
Immediately after measurement
Study Arms (2)
Glaucoma Suspects
EXPERIMENTALPatients with suspicion of glaucoma based on positive factors of disease.
Controls
ACTIVE COMPARATORAge matched controls to the glaucoma suspect group with no indications of glaucoma.
Interventions
Non-invasive recording of retinal potentials from a modulating pattern stimulus viewed on a visual display and recorded from surface electrodes around the eye.
Eligibility Criteria
You may qualify if:
- Age 18 to 85 years, inclusive
- Refractive errors within -5 to +3 diopters
- Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
- Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability \< 15% on all indices, normality \> 5% on all global indices in two consecutive sessions 6 months apart)
- Minimum untreated Intraocular pressure IOP of 15 mm Hg
- Glaucoma Suspect Status defined as one or more of the following:
- Glaucomatous optic disc appearance (vertical cup-to-disc ratio \[C/D\] ≥0.5
- Cup disc ratio asymmetry ≥0.2
- Localized thinning of the disc
- Presence or history of splinter disc hemorrhage
- Moderately increased IOP (\>21 to \<28 mm Hg).
- Family history of vision loss for glaucoma
You may not qualify if:
- Age-related macular degeneration
- Diabetes
- Parkinson's disease
- Multiple sclerosis
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
- Pregnant or nursing women.
- Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
- An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization.
- An OCT abnormal enough in a pattern consistent with glaucoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jorvec Corp.lead
- University of Miamicollaborator
Study Sites (1)
University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street
Miami, Florida, 33136, United States
Related Publications (6)
Porciatti V, Feuer WJ, Monsalve P, Triolo G, Vazquez L, McSoley J, Ventura LM. Head-down Posture in Glaucoma Suspects Induces Changes in IOP, Systemic Pressure, and PERG That Predict Future Loss of Optic Nerve Tissue. J Glaucoma. 2017 May;26(5):459-465. doi: 10.1097/IJG.0000000000000648.
PMID: 28263259BACKGROUNDPorciatti V, Chou TH. Modeling Retinal Ganglion Cell Dysfunction in Optic Neuropathies. Cells. 2021 Jun 5;10(6):1398. doi: 10.3390/cells10061398.
PMID: 34198840BACKGROUNDMonsalve P, Ren S, Triolo G, Vazquez L, Henderson AD, Kostic M, Gordon P, Feuer WJ, Porciatti V. Steady-state PERG adaptation: a conspicuous component of response variability with clinical significance. Doc Ophthalmol. 2018 Jun;136(3):157-164. doi: 10.1007/s10633-018-9633-2. Epub 2018 May 19.
PMID: 29779071BACKGROUNDMonsalve P, Triolo G, Toft-Nielsen J, Bohorquez J, Henderson AD, Delgado R, Miskiel E, Ozdamar O, Feuer WJ, Porciatti V. Next Generation PERG Method: Expanding the Response Dynamic Range and Capturing Response Adaptation. Transl Vis Sci Technol. 2017 May 22;6(3):5. doi: 10.1167/tvst.6.3.5. eCollection 2017 May.
PMID: 28553559BACKGROUNDToft-Nielsen J, Bohorquez J, Ozdamar O. Unwrapping of transient responses from high rate overlapping pattern electroretinograms by deconvolution. Clin Neurophysiol. 2014 Oct;125(10):2079-89. doi: 10.1016/j.clinph.2014.02.002. Epub 2014 Feb 14.
PMID: 24618216BACKGROUNDOzdamar O, Toft-Nielsen J, Bohorquez J, Porciatti V. Relationship between transient and steady-state pattern electroretinograms: theoretical and experimental assessment. Invest Ophthalmol Vis Sci. 2014 Dec 4;55(12):8560-70. doi: 10.1167/iovs.14-15685.
PMID: 25477321BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2024
First Posted
April 29, 2024
Study Start
June 1, 2023
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available six months after the completion of the project.
The results from the project will be shared by presenting results at scientific conferences and publishing results in scientific journals. In addition, a de-identified database containing subject gender, age at recording, raw localization and tracking data, will be maintained. The data will be shared with other centers conducting similar research under appropriate IRB approval.