NCT05747781

Brief Summary

The impact of glaucomatous optic neuropathy on the daily life of patients is poorly characterized and does not benefit from standardized tests. The development and validation of new tests could be used to assess the efficacy of innovative treatments for visually impaired patients and/or optimize management strategies.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Mar 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Mar 2023Mar 2027

First Submitted

Initial submission to the registry

February 2, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

4.1 years

First QC Date

February 2, 2023

Last Update Submit

February 17, 2023

Conditions

Optic Neuropathy

Outcome Measures

Primary Outcomes (3)

  • Discrimination capacity

    Number of patients with capacity of discrimintaion compared to healthy volunteers

    6 months

  • Reproducibility of performance tests

    Number of patients able to reproduce the same performance tests

    6 months

  • Analysis reationships between Performance Outcomes (PerfO), Patient-ReportedOutcome (PRO) and Clinical Outcomes.

    Number of patients in each situation

    6 months

Secondary Outcomes (2)

  • Postural control

    6 months

  • Oculomotricity:

    6 months

Study Arms (2)

Pilot Phase

ACTIVE COMPARATOR

12 patients with glaumatous optic neuropathy

Behavioral: Pilot Phase: standardized behavioral task

Validation Phase

PLACEBO COMPARATOR

66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment

Behavioral: Validation Phase: standardized behavioral task

Interventions

Pilot Phase: standardized behavioral taskBEHAVIORAL

Pilot Phase: * Mobility under variable light conditions (scotopic, photopic, glare, dark adaptation), performed in a virtual environment. * Visual search for objects in real life scenes (office, kitchen, living room) performed in a virtual environment. * Ability to drive (UFOV and DVFAT psychophysical tests).

Pilot Phase
Validation Phase: standardized behavioral taskBEHAVIORAL

Validation Phase: * Mobility in variable light conditions (photopic and scotopic), performed in real and virtual environments. * Visual search for objects in real scenes (office, kitchen, bedroom, living room) performed in a virtual environment. * Driving ability (two psychophysical tests UFOV and DVFAT, one supervised road test).

Validation Phase

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Glaucoma patients:
  • Age: 18 - 80 years,
  • Visual acuity of at least 6/10th binocular,
  • Patient followed at Quinze-Vingts and presenting with chronic stable glaucoma defined by the glaucoma ophthalmologist,
  • MMSE questionnaire score ≥ 25/30 or ≥ 16/25 (if the patient no longer drives),
  • Ability to give consent and comply with the study protocol,
  • Person with Social Security coverage.
  • Recruitment of glaucoma patients will be based on the criteria defined by the HPA classification (Appendix) on the basis of the Humphrey visual field, for categorization of patients into three stages of optic neuropathy progression (early stage "1", moderate "2" and advanced "3").
  • Always drivers in possession of a valid driver's license,
  • Driven at least 500 km in the past year.
  • Healthy volunteer:
  • Age: 18 - 80 years.
  • Age and sex matching between healthy volunteers and glaucoma patients (± 5 years).
  • MMSE questionnaire score ≥ 25/30.
  • Visual acuity of at least 10/10th in binocular.
  • +4 more criteria

You may not qualify if:

  • Pregnant women.
  • Inability to personally give consent.
  • Participants will not have neurodegenerative diseases or any other disease that could interfere with the assessments planned during this study.
  • Participants will not have any other ophthalmologic diseases other than glaucoma.
  • Drug treatments that may cause motor, visual, or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments.
  • Condition that limits ability to move.
  • Inability to read.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Christophe BAUDOUIN, Pr

    Hôpital National de la Vision des15-20

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil BROUK

CONTACT

+33140021126nbrouk@15-20.fr

Hayet SERHANE

CONTACT

+33140021144hserhane@15-20.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, longitudinal, non-randomized, open-label study with glaucoma patients and control group (healthy volunteers)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 28, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

February 28, 2023

Record last verified: 2023-02