To Study the Function of the Retina in Glaucoma Patients Using PERG

NCT03330574 | Unknown

• 1 other identifier: PERG-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the performance of a new diagnostic device in the diagnosis and management of glaucoma. We will use this new device (PERG) to evaluate the function of the retina in glaucoma patients. This device is safe for the patients.

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (4)

• Magnitude, μV

  Strength of the signal

  4 years

• Magnitude D, μV

  Strength and phase

  4 years

• MagD/Mag Ratio (no units)

  Ratio between MagD and Mag

  4 years

• SNR, dB

  Signal to Noise Ratio

  4 years

Study Arms (3)

Variability of the device

We will study the repeatability and reliability of the Diopsys® ERG Vision Testing Systems in normal non-glaucomatous people and in those with suspicion of glaucoma or confirmed glaucoma.

Diagnosis and progression of glaucoma

Patients who have a suspicion of glaucoma and patients with confirmed glaucoma will be included. PERG data obtained by the Diopsys® ERG Vision Testing Systems will be analyzed to study the PERG changes in different clinical situations, such as early glaucoma and progression of glaucoma.

Effect of medical/surgical intervention

Patients will undergo standard treatment based on their medical history and we will observe the PERG changes induced by these treatments (eye drops, laser or surgery) with the Diopsys® ERG Vision Testing Systems.

Eligibility Criteria

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

Study Population

All patients will be enrolled from glaucoma clinics of the Montchoisi glaucoma center

You may qualify if:

• Glaucoma (all types of glaucoma);
• Ocular hypertensive (Suspicion of glaucoma);
• Control Patients (without any suspicion/sign of glaucoma);
• Have given written informed consent, prior to any investigational procedures;
• Aged 18 years of either sex.

You may not qualify if:

• Patients not able to understand the character of the study
• Participation in other clinical research within the last 4 weeks
• Other diseases that may cause visual field loss or optic disc abnormalities
• Systemic diseases that may affect PERG amplitude such as diabetes, parkinsonism, multiple sclerosis
• Poor best corrected visual acuity outside the limits recommended for the test
• Patients with high myopia (\>5D)

Sponsors & Collaborators

• Swiss Vision Network: lead

Study Sites (1)

Montchoisi Clinic

Lausanne, Canton of Vaud, 1006, Switzerland

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Kaweh Mansouri, MD

  Glaucoma Center, Montchoisi Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 6, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)