Effect of Repeated Low-Level Red-Light Therapy on Visual Field Damage in Primary Open-angle Glaucoma

NCT ID: NCT05309811

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-09-30

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.

Conditions

Open Angle Glaucoma; Eye Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

RLRL therapy

Intervention Type: DEVICE

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 medications

Intervention Type: DRUG

Medications prescribed for IOP control by glaucoma specialists in the outpatient.

Group B

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

Group Type: EXPERIMENTAL

RLRL therapy

Intervention Type: DEVICE

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 medications

Intervention Type: DRUG

Medications prescribed for IOP control by glaucoma specialists in the outpatient.

Interventions

RLRL therapy

Each RLRL treatment lasts three minutes. RLRL treatments will be performed twice a day, with at least four hours between each RLRL treatment.

Intervention Type: DEVICE

Routine IOP-lowering medications

Medications prescribed for IOP control by glaucoma specialists in the outpatient.

Intervention Type: DRUG

Other Intervention Names

Repeated Low-Level Red-Light Therapy; Anti-glaucoma medications

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingguang He, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Mingguang He, MD, PhD

Role: CONTACT

mingguang_he@yahoo.com

8602087331906

Facility Contacts

Mingguang He, MD, PhD

Role: primary

mingguang_he@yahoo.com

8602087331906

Other Identifiers

2020KYPJ108

Identifier Type: -

Identifier Source: org_study_id