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

March 25, 2022 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: 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.
Other Names:
  • Repeated Low-Level Red-Light Therapy
Drug: Routine IOP-lowering medications
Medications prescribed for IOP control by glaucoma specialists in the outpatient.
Other Names:
  • Anti-glaucoma medications
Experimental: 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
Device: 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.
Other Names:
  • Repeated Low-Level Red-Light Therapy
Drug: Routine IOP-lowering medications
Medications prescribed for IOP control by glaucoma specialists in the outpatient.
Other Names:
  • Anti-glaucoma medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of mean deviations (MD) in visual field tests
Time Frame: 4 weeks and 16 weeks

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).
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

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).
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

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).
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

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).
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

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).
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

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).
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

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 (%).
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

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 (%).
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
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.
4 weeks, 12 weeks, 16 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Mingguang He, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020KYPJ108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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