STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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),

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pilot Phase: standardized behavioral task

    Behavioral

    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).

  • Validation Phase: standardized behavioral task

    Behavioral

    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).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Pilot PhaseActive comparator 1 intervention
Group B: Validation PhasePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Discrimination capacity

Number of patients with capacity of discrimintaion compared to healthy volunteers

Time frame
6 months
2

Reproducibility of performance tests

Number of patients able to reproduce the same performance tests

Time frame
6 months
3

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

Number of patients in each situation

Time frame
6 months

Secondary outcomes

1

Postural control

Number of patients with modification of Romberg quotient to assess whether the central nervous system has re-weighted the weight of visual, vestibular and proprioceptive inputs with the onset of glaucomatous optic neuropathy.

Time frame
6 months
2

Oculomotricity:

Number of patients with alteration of eye movement parameters during fixation tasks, ocular tracking (number of fixations, fixation error (gain), speed and number of catch-up saccades) and saccades) and ocular saccades.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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