Homonymous HemianopsiaNCT06674369
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 of Homonymous Hemianopsia, run by Okan University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 months
- Conditions the study is for
- Homonymous Hemianopsia
- What is being tested?
- Peli prism for hemianopia
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2022to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Okan University Hospital Ophthalmology clinic
Istanbul, Tuzla, 34939
About this study
Official 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
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.
- Conditions
- Homonymous Hemianopsia
- Being tested
- Peli prism for hemianopia
- Keywords
- Homonium hemianopsia, Retrograde ganglion cell degeneration, Neuroplastisity,, Vision therapy,, Peli Prism
- Medical subject headings
- Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peli prism for hemianopiaDevice
Also called Computerised visual filed examination, Optic coherence tomography
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Peli prism for hemianopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of prism use at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start28 Aug 2022
- Primary completion18 Oct 2022
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Homonymous HemianopsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Hatice Semrin Timlioglu İper, Okan University
- Investigators
- Aysun Sefay İdil, Professor, Study director, Ankara Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674369
- Sponsor's protocol ID
- 24.08.2022/20
- Status last verified
- Sep 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06674369
- Acronym / sponsor ID
- 24.08.2022/20
- Conditions
- Homonymous Hemianopsia
- Keywords
- Homonium hemianopsia, Retrograde ganglion cell degeneration, Neuroplastisity,, Vision therapy,, Peli Prism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 15 patients between the ages of 22-70 (m=52.0 year) with homonymous hemianopsia | – | Device: Peli prism for hemianopiaHomonymous 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. |
Who may qualify
- Ages
- 18 to 55 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peli prism for hemianopiaAlso: Computerised visual filed examination, Optic coherence tomographyPeli 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. | Device | 15 patients between the ages of 22-70 (m=52.0 year) with homonymous hemianopsia |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 31181393Garric 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Homonymous Hemianopsia
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Statistical Learning as a Novel Intervention for Cortical Blindness
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysun Sefay İdil, Professor study director
Ankara Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Homonymous Hemianopsia, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerised visual field changes (time frame: From enrollment to the end of prism use at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.