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| ID | Type | Description | Link |
|---|---|---|---|
| R21EY023720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.
Retinitis pigmentosa (RP) is a slowly progressive retinal degeneration for which there is no proven treatment. Patients are interested in trying alternative therapies to try to reduce their vision loss, but only limited research evidence exists to support their use and potential benefit. The goal of this research project is to gain a better understanding of possible changes in ocular and retinal blood flow and measures of vision in RP patients receiving two promising therapies, electroacupuncture and transcorneal electrical stimulation. We are currently only doing transcorneal electrical stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electro-acupuncture | Experimental | Electro-acupuncture applied to acupoints around the eye and traditional needle acupuncture applied to acupoints throughout the body at 10 half-hour sessions over 2 weeks |
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| Sham Electro-acupuncture | Sham Comparator | No electro-acupuncture applied to non-acupoints around the eye and traditional needle acupuncture applied to non-acupoints throughout the body; i.e., to locations not on the acupuncture meridians; at 10 half-hour sessions over 2 weeks |
|
| Laser acupuncture | Experimental | Laser applied to acupoints throughout the body at 10 sessions each lasting 15 minutes over a 2 week period |
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| Sham Laser acupuncture | Sham Comparator | An inactive sham laser (red light only) applied to non-acupoints throughout the body; i.e., to locations not on the acupuncture meridians; at 10 sessions each lasting 15 minutes over a 2 week period |
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| Transcorneal Electrical Stimulation | Experimental | Transcorneal Electrical Stimulation at 150% individual phosphene threshold applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-acupuncture | Device |
| ||
| Laser Acupuncture |
| Measure | Description | Time Frame |
|---|---|---|
| Significant changes from baseline in Goldmann visual field area in both eyes | Using Haig-Streit Octopus perimeter | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Significant changes from baseline in best-corrected ETDRS visual acuity at both 2 weeks and 6 weeks post-intervention initiation | Using Pelli-Robson visual acuity charts | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation |
| Changes in Macular edema Optical Coherence Tomography (OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth R Seger, OD, MSc | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Southeastern University; College of Optometry | Fort Lauderdale | Florida | 33328 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24773463 | Background | Bittner AK, Gould JM, Rosenfarb A, Rozanski C, Dagnelie G. A pilot study of an acupuncture protocol to improve visual function in retinitis pigmentosa patients. Clin Exp Optom. 2014 May;97(3):240-7. doi: 10.1111/cxo.12117. Epub 2013 Oct 29. | |
| 29222719 | Result | Bittner AK, Seger K. Longevity of visual improvements following transcorneal electrical stimulation and efficacy of retreatment in three individuals with retinitis pigmentosa. Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):299-306. doi: 10.1007/s00417-017-3858-8. Epub 2017 Dec 8. |
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|
| Sham Transcorneal Electrical Stimulation | Sham Comparator | Sham Transcorneal Electrical Stimulation at 0% individual phosphene threshold (no stimulation) applied to both eyes using DTL electrodes at 6 weekly 30 minute sessions |
|
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| Transcorneal Electrical Stimulation | Device |
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| Sham Electro-acupuncture | Device |
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| Sham laser acupuncture | Device |
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| Sham transcorneal electrical stimulation | Device |
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Using Optical Coherence Tomography |
| twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation |
| Significant changes from baseline in contrast sensitivity at both 2 weeks and 6 weeks post-intervention initiation | Using Adaptive Sensory Technology Quick CSF | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation |
| Significant changes from baseline in Dark adaptation function at both 2 weeks and 6 weeks post-intervention initiation | Using the AdaptDx by Maculogix | twice at baseline, then 2 weeks, 6 weeks and 12 weeks post-intervention initiation |
| 29130647 | Result | Bittner AK, Seger K, Salveson R, Kayser S, Morrison N, Vargas P, Mendelsohn D, Han J, Bi H, Dagnelie G, Benavente A, Ramella-Roman J. Randomized controlled trial of electro-stimulation therapies to modulate retinal blood flow and visual function in retinitis pigmentosa. Acta Ophthalmol. 2018 May;96(3):e366-e376. doi: 10.1111/aos.13581. Epub 2017 Nov 11. |
| 28910168 | Result | Kayser S, Vargas P, Mendelsohn D, Han J, Bi H, Benavente A, Bittner AK. Reduced Central Retinal Artery Blood Flow Is Related to Impaired Central Visual Function in Retinitis Pigmentosa Patients. Curr Eye Res. 2017 Nov;42(11):1503-1510. doi: 10.1080/02713683.2017.1338350. Epub 2017 Sep 14. |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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