Fresnel PrismNCT07531667
Fresnel Prism in Low Vision Patients With Homonymous Hemianopia Defect in Cipto Mangunkusumo Hospital
A study testing Fresnel prism in people with Fresnel Prism, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fresnel Prism
- What is being tested?
- Fresnel prism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2022to 1 Aug 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ocular motility disorders; the primary position of the eyeball was not orthophoric; and
- walking disorders that resulted in poor fixation of glasses.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia
Jakarta, DKI Jakarta, 14430
About this study
Official title: 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.
Read the detailed description
: Fresnel prisms with a power of 40∆ were fitted to the patient's spectacles for two weeks. Visual field parameters were analysed using the Humphrey Field Analyzer with the SITA 24-2 algorithm, while the Pelli-Robson and ETDRS charts were used to assess contrast sensitivity and visual acuity, respectively. After visual assessment, comfort was quantitatively assessed using a comfort scale.
- Conditions
- Fresnel Prism
- Being tested
- Fresnel prism
- Keywords
- homonymous hemianopia, fresnel prism, visual field impairment
- Medical subject headings
- Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresnel prismDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Fresnel prism | Experimental | 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 Receives: Device: Fresnel prism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Fied
Mean Deviation (dB) Pattern Standard deviation (dB) Visual field index (%)
Measured: 2 weeks
Secondary outcomes (2)
TPDK
Sharp vision with correction (log mar)
Measured: 2 weeks
Contrast sensitivity
Contrast sensitivity (log units)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 May 2022
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fresnel PrismStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Tri Rahayu, SpM(K), FIACLE, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531667
- Sponsor's protocol ID
- 23-06-0925
- Other IDs
- PUTI Saintekes 2020 Grant
- Status last verified
- May 2022
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to patient privacy considerations
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fresnel Prism in Low Vision Patients With Homonymous Hemianopia Defect in Cipto Mangunkusumo Hospital
- ClinicalTrials.gov ID
- NCT07531667
- Acronym / sponsor ID
- 23-06-0925
- Conditions
- Fresnel Prism
- Keywords
- homonymous hemianopia, fresnel prism, visual field impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 15 Apr 2026 (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.
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.
Detailed description
: Fresnel prisms with a power of 40∆ were fitted to the patient's spectacles for two weeks. Visual field parameters were analysed using the Humphrey Field Analyzer with the SITA 24-2 algorithm, while the Pelli-Robson and ETDRS charts were used to assess contrast sensitivity and visual acuity, respectively. After visual assessment, comfort was quantitatively assessed using a comfort scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fresnel prism | Experimental | Device: Fresnel prismThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- ocular motility disorders; the primary position of the eyeball was not orthophoric; and
- walking disorders that resulted in poor fixation of glasses.
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 |
|---|---|---|
| Fresnel prismThe 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. | Device | Fresnel prism |
Primary outcome
Visual Fied
Time frame: 2 weeks
Mean Deviation (dB) Pattern Standard deviation (dB) Visual field index (%)
2 secondary outcomes
TPDK
Time frame: 2 weeks
Contrast sensitivity
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared due to patient privacy considerations
Related trials for Fresnel Prism
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresnel prism in people with Fresnel Prism, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 15 Apr 2026. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Fied (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.