N/A
N=33
Efficacy of Acupuncture in Macular Diseases
Age-related Macular Degeneration · Stargardt Disease · Macular Dystrophy
Bottom Line
View on ClinicalTrials.gov: NCT02255981 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study — 36; 16; 4 Eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture and massage (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Escuela Neijing
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study |
36; 16; 4 | — |
| PRIMARY Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart. |
20; 29; 3; 4; 9; 8 | — |
| PRIMARY Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart |
41.5178; 53.5714; 14.3571 | <0.05 sig |
| PRIMARY Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture. |
13 | — |
| SECONDARY Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow) |
61.45 | — |
| SECONDARY Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment. |
— | — |
Summary
This is a single-arm study designed to assess the efficacy of acupuncture (Traditional Chinese Medicine) for chronic macular diseases of several types. All participants received acupuncture and massage and there is not a placebo group because it is not considered a good form to evaluate in Chinese Medicine due to, acupuncturing being a procedure is not as blind as is desired. As a control of the results in this trial, the outcomes could be contrasted against those reported in known medical publications and against expectations of the progress of the damage without treatment.
Eligibility Criteria
Inclusion Criteria
- • Clinical diagnosis of Macular Disease.
- The patient must accept treatment with acupuncture
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02255981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.