Clinical trial NCT05309811: Effect of Repeated Low-Level Red-Light Therapy on Visual Field Damage in Primary Open-angle Glaucoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Angle Glaucoma
Eye Diseases
Keywords: Open-angle glaucoma
Repeated low-level red-light therapy
Visual field
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-69 years;
2. Diagnosis of primary open-angle glaucoma with definite visual field defects in either eye (MD \<-3dB);
3. Well-controlled IOP in both eyes (IOP\<21mmHg).

Exclusion Criteria:

1. Severe visual field defects in either eye (MD \<-22dB);
2. Visual field defects caused by other diseases in either eye;
3. Unreliable results of visual field or IOP measurements in either eye;
4. Diagnosis of other ocular diseases in active phase in either eye;
5. History of refractive surgeries in either eye;
6. History of other ophthalmic laser treatments or intraocular surgeries in the last 3 months in either eye;
7. Refusing to inform consents or having difficulties to take part in follow-ups in next 6 months.

Primary outcomes:
measure: Changes of mean deviations (MD) in visual field tests
timeFrame: 12 weeks and 24 weeks
Secondary outcomes:
measure: Changes of mean deviations (MD) in visual field tests
timeFrame: 4 weeks and 16 weeks
measure: Incidence rates of significant reversal of visual field damages
timeFrame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
measure: Changes of pattern standard deviations (PSD) in visual field tests
timeFrame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
measure: Changes of the thickness of parapapillary retinal nerve fiber layer
timeFrame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
measure: Changes of the thickness of perifoveal ganglion cell-inner plexiform layer
timeFrame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
measure: Changes of the thickness of central macular choroid
timeFrame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
measure: Changes of the parapapillary capillary density
timeFrame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
measure: Change of the perifoveal capillary density
timeFrame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
measure: Incidence rates of treatment-emergent adverse events
timeFrame: 4 weeks, 12 weeks, 16 weeks and 24 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Mingguang He, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: