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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43EY025508-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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The purpose of this research study is to determine if photobiomodulation is an effective treatment of Dry Age-Related Macular Degeneration (AMD) and vision loss associated with the disease.
The LumiThera LT 300® Light Delivery System is a stationary desktop instrument used to emit energy in the visible and near infrared spectrum. The LT-300® is designed for the ophthalmologist to use in the treatment of the eye with photobiomodulation (PBM), a process by which cellular mechanisms are induced by light. PBM is being utilized in many indications, such as wound healing, soft tissue injuries, joint pain, myofascial pain, nerve injuries, muscle fatigue for temporary improvement in blood flow and reduction in inflammation. The mechanism of PBM at the cellular level has been ascribed to the activation of mitochondrial respiratory chain components resulting in stabilization of metabolic function and initiation of a signaling cascade, which promotes cellular proliferation and cytoprotection. The LT-300® will provide a preset treatment of PBM to the subject's eye and retinal tissue through the open and closed eyelid.
Approximately 30 subjects meeting the eligibility requirements of the study will be randomly assigned in a 1:1 ratio to receive standard of care treatment for Dry AMD plus PBM treatment with the LT-300 system, or standard of care treatment for Dry AMD plus Sham treatment with the LT-300 system. Subjects randomized to each group will receive two 3-week treatment sessions (9 treatments per session) and follow-up visits extending to one year. The primary objective of the study is to evaluate the safety and efficacy of PBM with respect to visual and anatomical outcomes of subjects with Dry AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photobiomodulation Treatment | Experimental | Treatment with Photobiomodulation to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months. |
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| Sham Treatment | Sham Comparator | Sham treatment to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LT-300 Active (PBM) | Device |
| ||
| LT-300 Inactive (Sham) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity changes from baseline to month 12. | Visual acuity will be measured using ETDRS VA letter scoring to test the difference between the sham and treatment subjects in mean change from Baseline to Month 12 | Through study completion, an average of one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Sensitivity | Contrast Sensitivity will be measured using the FACT Contrast Sensitivity Chart to test the difference between the sham and treatment subjects in mean change from Baseline to Month 12 | Through study completion, an average of one year. |
| Optical Coherence Tomography (OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Markowitz, MD | Private Practice | Principal Investigator |
| Robert G Devenyi, MD | Ophthalmologist in Chief and Director of Retinal Services, The Donald K. Johnson Eye Center, University Health Network; Professor of Ophthalmology, The University of Toronto; Vitreoretinal Surgery Lead, The Kensington Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1929 Bayview Avenue, Unit 117 | Toronto | Ontario | M4G 3E8 | Canada |
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| Label | URL |
|---|---|
| LIGHTSITE I Results | View source |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
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| Device |
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OCT will be measured using the Spectralis SD-OCT to compare changes in dry AMD pathology. |
| Through study completion, an average of one year. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |