Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06674369

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 month–55 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Okan University Hospital Ophthalmology clinic

Istanbul, Tuzla, 34939, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Computerised visual filed examination, Optic coherence tomography

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Okan University

Other

Collaborators

  • Ankara University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.