An interventional study of RLRL therapy and Routine IOP-lowering medications in Open Angle Glaucoma and Eye Diseases, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 44 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.
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Exclusion Criteria:
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
Device: RLRL therapy · Drug: Routine IOP-lowering medications
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
Device: RLRL therapy · Drug: Routine IOP-lowering medications
Each RLRL treatment lasts three minutes. RLRL treatments will be performed twice a day, with at least four hours between each RLRL treatment.
Also known as: Repeated Low-Level Red-Light Therapy
Medications prescribed for IOP control by glaucoma specialists in the outpatient.
Also known as: Anti-glaucoma medications
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).
Time frame: 12 weeks and 24 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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 (%).
Time frame: 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.
Time frame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Plan to share: Yes
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Zhongshan Ophthalmic Center, Sun Yat-sen University