- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531667
Fresnel Prism in Low Vision Patients With Homonymous Hemianopia Defect in Cipto Mangunkusumo Hospital
Use of Fresnel Prism in Low Vision Patients With Homonymous Hemianopia Defect in Cipto Mangunkusumo Hospital
Background: Homonymous hemianopia is a visual field defect that causes functional disabilities, such as decreased self-confidence, limited mobility, and increased risk of falls. Studies related to the effectiveness and comfort of Fresnel prisms, especially in the Indonesian population are limited.
Objective: To evaluate the effectiveness and comfort level of Fresnel prisms in expanding visual field in an Indonesian patient population with homonymous hemianopia.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 14430
- Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- subjects with a diagnosis of partial or complete homonymous hemianopia based on the results of the Humphrey perimetry examination;
- age 18 years or older;
- corrected visual acuity of 6/18 or better; and
- willing to give consent for this study and consistently follow the rehabilitation process.
Exclusion Criteria:
- ocular motility disorders; the primary position of the eyeball was not orthophoric; and
- walking disorders that resulted in poor fixation of glasses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fresnel prism
The Fresnel prism chosen was of 40∆ power (the largest size available) with the aim of the largest visual field expansion, which was 20 degrees that the patient felt during environmental orientation and mobilisation.
Fresnel prism fitting was performed using the patient's spectacles (if wearing spectacles) or plano glasses provided by the researcher.
The patient was then asked to practice scanning before being asked to wear the Fresnel prism for 5.5 hours daily for two weeks.
Patients were given a wear sheet to evaluate the duration of wear in a day
|
The Fresnel prism chosen was of 40∆ power (the largest size available) with the aim of the largest visual field expansion, which was 20 degrees that the patient felt during environmental orientation and mobilisation.
Fresnel prism fitting was performed using the patient's spectacles (if wearing spectacles) or plano glasses provided by the researcher.
The patient was given object movement stimulation to identify the visual field boundary and the Fresnel prism was placed 2 mm away from the healthy visual field area.
The Fresnel prism was placed on the inner side of the lens.
Vertical correction was performed in homonymous hemianopia depending on the visual field defect.
The patient was then asked to practice scanning before being asked to wear the Fresnel prism for 5.5 hours daily for two weeks.
Patients were given a wear sheet to evaluate the duration of wear in a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Fied
Time Frame: 2 weeks
|
Mean Deviation (dB) Pattern Standard deviation (dB) Visual field index (%)
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TPDK
Time Frame: 2 weeks
|
Sharp vision with correction (log mar)
|
2 weeks
|
|
Contrast sensitivity
Time Frame: 2 weeks
|
Contrast sensitivity (log units)
|
2 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-06-0925
- PUTI Saintekes 2020 Grant (Other Identifier: Universitas Indonesia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Informed Consent Form
Information identifier: tri.rahayu01@ui.ac.id
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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