Ongoing Effect of Expansion Prisms Following the Discontinuation of Use on Visual Field Enlargement and Retrograde Ganglion Cell Degeneration in Homonymous Hemianopia Patients

NCT06674369 | Active Not Recruiting DMC

• 1 other identifier: 24.08.2022/20
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the long-term effects of Pelli prism in Hemianopia patients who take Prisms for awareness of the area they cannot see. The main question it aims to answer is: Does the field enlargement observed with the prism continues after the prism is removed? Participants already using Peli prisms as part of their regular medical care for Hemianopia, in the upcoming routine controls their field of vision enlargements will be examined.

Conditions

Homonymous Hemianopsia

Keywords

Homonium hemianopsia; Retrograde ganglion cell degeneration; Neuroplastisity,; Vision therapy,; Peli Prism

Outcome Measures

Primary Outcomes (1)

• Computerised visual field changes

  Changes in Visual field index(VFİ) and mean devation(MD) in dB. Higher values in VFI and MD mean an improvement in visual field

  From enrollment to the end of prism use at 6 months

Study Arms (1)

15 patients between the ages of 22-70 (m=52.0 year) with homonymous hemianopsia

Homonymous hemianopia (HH) patients due to long-standing post-chiasmatic lesions between 2017 and 2020 were included in the study . To eliminate spontaneous neuronal recovery only the patients with hemianopia, diagnosed at least six months before the initial examination and who had undergone full clinical MRI evaluation were included. Initially all patients were applied peripheral field expander 40 D horizontal Peli prisms. In the initial and follow-up examinations, in addition to neurological history, a complete ophthalmologic examination was performed, followed by computerized visual field examination using Estermann binocular field program and Swedish Interactive treshold algorithm program (SITA 30-2) (Zeiss Humphrey3-850). Ganglion cell layer thickness was measured by OCT (Zeiss Cirrus HD Oct) and compared with the normal retinal image.

Device: Peli prism for hemianopia

Interventions

Peli prism for hemianopia DEVICE

Peli prism uses high-powered prisms (40 Dioptre) that expand a hemianopic patient's awareness of their blind side. This awareness enables patients to better detect obstacles and navigate around them. Effect of the prism considered as temporary We investigated whether the effect persists after the prism is removed.To understand the persistence of the effect, we examined the changes in the visual field with CVF (Computerized visual field examination)before the prism was applied, with the prism and 1 week after the prism was removed.

Also known as: Computerised visual filed examination, Optic coherence tomography

15 patients between the ages of 22-70 (m=52.0 year) with homonymous hemianopsia

Eligibility Criteria

• Age: 18 Months - 55 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hemianopia patients admitted to the ophthalmology clinic of Okan University Hospital and the ophthalmology clinic of Ankara University Faculty of Medicine were included in the study.

You may qualify if:

• Homonim Hemianopsia patient age between 18-55 years H.Hemianopia, diagnosed at least six months before the initial examination Neurological condition is suitable for daily activities

You may not qualify if:

• \- Failure to meet age criteria Hemianopia developed more recently than 6 months ago Having to use medications that affect his/her balance and daily activity

Sponsors & Collaborators

• Okan University: lead
• Ankara University: collaborator

Study Sites (1)

Okan University Hospital Ophthalmology clinic

Istanbul, Tuzla, 34939, Turkey (Türkiye)

Location

Related Publications (1)

• Garric C, Sebaa A, Caetta F, Perez C, Savatovsky J, Sergent C, Chokron S. Dissociation between objective and subjective perceptual experiences in a population of hemianopic patients: A new form of blindsight? Cortex. 2019 Aug;117:299-310. doi: 10.1016/j.cortex.2019.05.006. Epub 2019 May 18.

  PMID: 31181393 BACKGROUND

Related Links

• The risk of pedestrian collisions with peripheral visual field loss. Journal of vision, 16(15), 5-5

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aysun Sefay İdil, Professor

  Ankara Üniversity

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 5, 2024
• Study Start: August 28, 2022
• Primary Completion: October 18, 2022
• Study Completion: October 30, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2.12.2024
• Access Criteria: Open access for academics

Locations

TU (1)