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

November 3, 2024 updated by: Hatice Semrin Timlioglu İper, Okan University

Timlioğlu İper H.S1, Sahli.E2, İdil Ş.A3,Önal.R.E4 1 PhD.MD Opht.İstanbul Okan University ,ophthalmology and Opticianry ,ORCİD:0000-0003-2112-0602 2 PhD.MD Opht. Ankara University Faculty of Medicine, Low Vision Rehabilitation and Research Center, Department of Ophthalmology, Ankara, Turkey ORCİD:0000-0002-1355-7284 3 MD Opht. Professor. Ankara University Faculty of Medicine, Low Vision Rehabilitation and Research Center, Department of Ophtha

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Tuzla
      • İstanbul, Tuzla, Turkey, 34939
        • Okan University Hospital Ophthalmology clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

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.

Description

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:

- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Computerised visual filed examination
  • Optic coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computerised visual field changes
Time Frame: From enrollment to the end of prism use at 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Collaborators

Ankara University

Investigators

  • Study Director: Aysun Sefay İdil, Professor, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2022

Primary Completion (Actual)

October 18, 2022

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

November 3, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24.08.2022/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

2.12.2024

IPD Sharing Access Criteria

Open access for academics

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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