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Active, not recruitingNCT06674369Updated Nov 5, 2024

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

An observational study in Homonymous Hemianopsia, sponsored by Okan University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Months to 55 Months. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Okan University · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
15
Ages
18 Months to 55 Months
Sex
All
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Study 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.

Read the detailed description

Hemianopia is a disability-causing condition that usually affects young to middle-aged people and reduces quality of life.Prism applications are one of the rehabilitation methods used to improve the quality of life of these people and ensure their participation in daily life. The Peli prism is the most commonly used prism type. The effect of prism applications is thought to be temporary.The main idea of our study is that Prisms can create longlasting effects by affecting neuroplasticity.

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Conditions studied

  • Homonymous Hemianopsia

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Keywords

  • Homonium hemianopsia
  • Retrograde ganglion cell degeneration
  • Neuroplastisity,
  • Vision therapy,
  • Peli Prism
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In context

Hemianopsia

63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.

Browse Hemianopsia studies →

Lead sponsor

Okan University is the lead sponsor of 97 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Months to 55 Months
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DevicePeli prism for hemianopia

    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

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What researchers measure

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

    Time frame: From enrollment to the end of prism use at 6 months

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 31181393 ↗

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 2.12.2024

Access criteria: Open access for academics

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06674369
Lead sponsor
Okan University
Collaborators
Ankara University
Responsible party
Hatice Semrin Timlioglu İper (Assistant Professor, Okan University) — Principal investigator
First posted
Nov 5, 2024
Start date
Aug 28, 2022
Primary completion
Oct 18, 2022
Completion
Oct 30, 2024 (estimated)
Last update
Nov 5, 2024

Study contacts

Aysun Sefay İdil, Professor
study director · Ankara Üniversity

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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