Open Angle GlaucomaNCT05309811
Effect of Repeated Low-Level Red-Light Therapy on Visual Field Damage in Primary Open-angle Glaucoma
A study testing RLRL therapy and Routine IOP-lowering medications in people with Open Angle Glaucoma and Eye Diseases, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to investigate the effect of repeated low-level red-light therapy on existing visual field damages in primary open-angle glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Open Angle Glaucoma, Eye Diseases
- What is being tested?
- RLRL therapy and Routine IOP-lowering medications
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Sep 2023
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-69 years;
- Diagnosis of primary open-angle glaucoma with definite visual field defects in either eye (MD <-3dB);
- Well-controlled IOP in both eyes (IOP<21mmHg).
Who cannot join
- Severe visual field defects in either eye (MD <-22dB);
- Visual field defects caused by other diseases in either eye;
- Unreliable results of visual field or IOP measurements in either eye;
- Diagnosis of other ocular diseases in active phase in either eye;
- History of refractive surgeries in either eye;
- History of other ophthalmic laser treatments or intraocular surgeries in the last 3 months in either eye;
- Refusing to inform consents or having difficulties to take part in follow-ups in next 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Mingguang He, MD, PhD, 8602087331906, mingguang_he@yahoo.com
About this study
Official title: Effect of Repeated Low-Level Red-Light Therapy on Visual Field Damage in Primary Open-angle Glaucoma: A Randomized Cross-over Clinical Trial
The purpose of this study is to investigate the effect of repeated low-level red-light therapy on existing visual field damages in primary open-angle glaucoma patients.
Read the detailed description
Glaucoma is one of the main causes of visual impairment worldwide. Elevated intraocular pressure (IOP) is an important risk factor for glaucoma and the majority of anti-glaucoma therapies focus on the control of IOP. However, IOP-lowering treatments cannot directly attenuate optic neurodegeneration and rescue vulnerable retinal ganglion cells (RGCs). The glaucomatous symptoms could continue to deteriorate in some patients after optimal IOP control, which highlighted the need for alternative therapies targeting neuroprotection.
Chronic ischemia is another potential factor in the pathogenesis of glaucoma. Clinical trials suggested that calcium channel blockers such as nilvadipine could increase ocular blood flow and postpone visual field deterioration in normal-tension glaucoma. Furthermore, it was found that Ginkgo biloba extract, another vasoactive drug, could reverse existing visual field damages, which indicated that improved ocular circulation would salvage dysfunctional RGCs and its efficacy could be observed in a relatively short time frame.
The repeated low-level red-light (RLRL) therapy has regulatory effects on blood supply, which provides an innovative and non-invasive approach for the treatment of glaucoma. Considering the possible ischemic mechanism of POAG, it is expected that RLRL therapy could improve ocular circulation and reverse compromised visual functions. Using a randomized clinical trial with cross-over design, the purpose of this study is to investigate the effect of RLRL therapy on existing visual field damages in POAG patients.
This study is a 24-week, prospective, randomized, cross-over clinical trial, enrolling POAG patients with well-controlled IOP as participants. Study participants will be randomly allocated to two groups, with one group receiving RLRL therapy from the 1st to the 12th week and the other receiving RLRL therapy from the 13th to the 24th week. Use of IOP-lowering medications is allowed throughout the 24 weeks. An interim analysis to ensure the safety of RLRL therapy is scheduled after the 12th week. Linear mixed models will be used to determine changes in visual field and assess other secondary outcomes.
- Conditions
- Open Angle Glaucoma, Eye Diseases
- Being tested
- RLRL therapy, Routine IOP-lowering medications
- Keywords
- Open-angle glaucoma, Repeated low-level red-light therapy, Visual field
- Medical subject headings
- Glaucoma, Open-Angle, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLRL therapyDevice
Also called Repeated Low-Level Red-Light Therapy
Each RLRL treatment lasts three minutes. RLRL treatments will be performed twice a day, with at least four hours between each RLRL treatment.
Routine IOP-lowering medicationsDrug
Also called Anti-glaucoma medications
Medications prescribed for IOP control by glaucoma specialists in the outpatient.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | RLRL therapy with routine IOP-lowering medications in the 1st-12th weeks then crossing to only routine IOP-lowering medications in the 13th-24th weeks Receives: Device: RLRL therapy; Drug: Routine IOP-lowering medications |
| Group B | Experimental | Only routine IOP-lowering medications in the 1st-12th weeks then crossing to RLRL therapy with routine IOP-lowering medications in the 13th-24th weeks Receives: Device: RLRL therapy; Drug: Routine IOP-lowering medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of mean deviations (MD) in visual field tests
The twelve-week changes of MD are characterized as differences between the 12-week follow-up visit and the baseline visit or differences between the 24-week visit and the 12-week follow-up visit. The Humphrey Visual Field Analyzer will be used to measure MD (dB).
Measured: 12 weeks and 24 weeks
Secondary outcomes (9)
Changes of mean deviations (MD) in visual field tests
The four-week changes of MD are characterized as differences between the 4-week follow-up visit and the baseline visit or differences between the 16-week visit and the 12-week follow-up visit.
The Humphrey Visual Field Analyzer will be used to measure MD (dB).
Measured: 4 weeks and 16 weeks
Incidence rates of significant reversal of visual field damages
The four-week and twelve-week incidence rates of significant reversal of visual field damages are rates of POAG patients with MD reversal ≥ 3dB between the 4-/12week follow-up visits and the baseline visit or between the 16-/24-week follow-up visits and the 12-week follow-up visit.
The Humphrey Visual Field Analyzer will be used to measure MD (dB).
Measured: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of pattern standard deviations (PSD) in visual field tests
The four-week and twelve-week changes of PSD are characterized as differences between the 4-/12week follow-up visit and the baseline visit or differences between the 16-/24-week visit and the 12-week follow-up visit.
The Humphrey Visual Field Analyzer will be used to measure PSD (dB).
Measured: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of the thickness of parapapillary retinal nerve fiber layer
The four-week and twelve-week changes of the thickness of parapapillary retinal nerve fiber layer (RNFL) are characterized as differences between the 4-/12week follow-up visits and the baseline visit or differences between the 16-/24-week follow-up visits and the 12-week follow-up visit.
Spectralis HRA OCT and Optovue OCT will be used to measure the thickness of parapapillary RNFL (μm).
Measured: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of the thickness of perifoveal ganglion cell-inner plexiform layer
The four-week and twelve-week changes of the thickness of perifoveal ganglion cell-inner plexiform (CG-IPL) are characterized as differences between the 4-/12week follow-up visits and the baseline visit or differences between the 16-/24-week follow-up visits and the 12-week follow-up visit.
Spectralis HRA OCT and Optovue OCT will be used to measure the thickness of perifoveal CG-IPL (μm).
Measured: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of the thickness of central macular choroid
The four-week and twelve-week changes of the thickness of central macular choroid are characterized as differences between the 4-/12week follow-up visits and the baseline visit or differences between the 16-/24-week follow-up visits and the 12-week follow-up visit.
DRI OCT Triton and Optovue OCT will will be used to measure the thickness of central macular choroid (μm).
Measured: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of the parapapillary capillary density
The four-week and twelve-week changes of parapapillary capillary density (CD) are characterized as differences between the 4-/12week follow-up visits and the baseline visit or differences between the 16-/24-week follow-up visits and the 12-week follow-up visit.
DRI OCT Triton and Optovue OCT will will be used to measure parapapillary CD (%).
Measured: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Change of the perifoveal capillary density
The four-week and twelve-week changes of perifoveal capillary density (CD) are characterized as differences between the 4-/12week follow-up visits and the baseline visit or differences between the 16-/24-week follow-up visits and the 12-week follow-up visit.
DRI OCT Triton and Optovue OCT will be used to measure perifoveal CD (%).
Measured: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Incidence rates of treatment-emergent adverse events
The four-week and twelve-week incidence rates of treatment-emergent adverse events are rates of treatment-emergent adverse events between the 4-/12week follow-up visits and the baseline visit or between the 16-/24-week follow-up visits and the 12-week follow-up visit. Subjects will be asked to report any treatment-emergent adverse event, including but not limited to glare, flash blindness, and afterimages.
Measured: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingguang He, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309811
- Sponsor's protocol ID
- 2020KYPJ108
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repeated Low-Level Red-Light Therapy on Visual Field Damage in Primary Open-angle Glaucoma: A Randomized Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT05309811
- Acronym / sponsor ID
- 2020KYPJ108
- Conditions
- Open Angle Glaucoma, Eye Diseases
- Keywords
- Open-angle glaucoma, Repeated low-level red-light therapy, Visual field
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 4 Apr 2022 (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 purpose of this study is to investigate the effect of repeated low-level red-light therapy on existing visual field damages in primary open-angle glaucoma patients.
Detailed description
Glaucoma is one of the main causes of visual impairment worldwide. Elevated intraocular pressure (IOP) is an important risk factor for glaucoma and the majority of anti-glaucoma therapies focus on the control of IOP. However, IOP-lowering treatments cannot directly attenuate optic neurodegeneration and rescue vulnerable retinal ganglion cells (RGCs). The glaucomatous symptoms could continue to deteriorate in some patients after optimal IOP control, which highlighted the need for alternative therapies targeting neuroprotection.
Chronic ischemia is another potential factor in the pathogenesis of glaucoma. Clinical trials suggested that calcium channel blockers such as nilvadipine could increase ocular blood flow and postpone visual field deterioration in normal-tension glaucoma. Furthermore, it was found that Ginkgo biloba extract, another vasoactive drug, could reverse existing visual field damages, which indicated that improved ocular circulation would salvage dysfunctional RGCs and its efficacy could be observed in a relatively short time frame.
The repeated low-level red-light (RLRL) therapy has regulatory effects on blood supply, which provides an innovative and non-invasive approach for the treatment of glaucoma. Considering the possible ischemic mechanism of POAG, it is expected that RLRL therapy could improve ocular circulation and reverse compromised visual functions. Using a randomized clinical trial with cross-over design, the purpose of this study is to investigate the effect of RLRL therapy on existing visual field damages in POAG patients.
This study is a 24-week, prospective, randomized, cross-over clinical trial, enrolling POAG patients with well-controlled IOP as participants. Study participants will be randomly allocated to two groups, with one group receiving RLRL therapy from the 1st to the 12th week and the other receiving RLRL therapy from the 13th to the 24th week. Use of IOP-lowering medications is allowed throughout the 24 weeks. An interim analysis to ensure the safety of RLRL therapy is scheduled after the 12th week. Linear mixed models will be used to determine changes in visual field and assess other secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: RLRL therapy, Drug: Routine IOP-lowering medicationsRLRL therapy with routine IOP-lowering medications in the 1st-12th weeks then crossing to only routine IOP-lowering medications in the 13th-24th weeks |
| Group B | Experimental | Device: RLRL therapy, Drug: Routine IOP-lowering medicationsOnly routine IOP-lowering medications in the 1st-12th weeks then crossing to RLRL therapy with routine IOP-lowering medications in the 13th-24th weeks |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-69 years;
- Diagnosis of primary open-angle glaucoma with definite visual field defects in either eye (MD <-3dB);
- Well-controlled IOP in both eyes (IOP<21mmHg).
Key exclusion criteria (7 listed)
- Severe visual field defects in either eye (MD <-22dB);
- Visual field defects caused by other diseases in either eye;
- Unreliable results of visual field or IOP measurements in either eye;
- Diagnosis of other ocular diseases in active phase in either eye;
- History of refractive surgeries in either eye;
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 |
|---|---|---|
| RLRL therapyAlso: Repeated Low-Level Red-Light TherapyEach RLRL treatment lasts three minutes. RLRL treatments will be performed twice a day, with at least four hours between each RLRL treatment. | Device | Group A, Group B |
| Routine IOP-lowering medicationsAlso: Anti-glaucoma medicationsMedications prescribed for IOP control by glaucoma specialists in the outpatient. | Drug | Group A, Group B |
Primary outcome
Changes of mean deviations (MD) in visual field tests
Time frame: 12 weeks and 24 weeks
The twelve-week changes of MD are characterized as differences between the 12-week follow-up visit and the baseline visit or differences between the 24-week visit and the 12-week follow-up visit. The Humphrey Visual Field Analyzer will be used to measure MD (dB).
9 secondary outcomes
Changes of mean deviations (MD) in visual field tests
Time frame: 4 weeks and 16 weeks
Incidence rates of significant reversal of visual field damages
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of pattern standard deviations (PSD) in visual field tests
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of the thickness of parapapillary retinal nerve fiber layer
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of the thickness of perifoveal ganglion cell-inner plexiform layer
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of the thickness of central macular choroid
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Changes of the parapapillary capillary density
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Change of the perifoveal capillary density
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Incidence rates of treatment-emergent adverse events
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: Yes
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The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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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.
Mingguang He, MD, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RLRL therapy and Routine IOP-lowering medications in people with Open Angle Glaucoma and Eye Diseases, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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 3 inclusion and 7 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 4 Apr 2022. 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 China. 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?
Contact Mingguang He, MD, PhD (8602087331906, mingguang_he@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of mean deviations (MD) in visual field tests (time frame: 12 weeks and 24 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 4 Apr 2022.