This trial is active, not recruiting.

Condition macular degeneration
Treatment traditional chinese medicine (tcm) acupuncture
Sponsor Escuela Neijing
Start date March 2013
End date May 2016
Trial size 33 participants
Trial identifier NCT02255981, Neijing Ophthalmology


The purpose is to assess the efficacy of acupuncture (Traditional Chinese Medicine) for chronic macular diseases, and help to solve a problem for cases that have no treatment, no response to the conventional treatment, or have no access to medical treatment.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Traditional Chinese Medicine (TCM). All cases in this group receive treatment with acupuncture. The protocol is the same for all by treat and extend program.
traditional chinese medicine (tcm) acupuncture acupuncture chinese style
Treatment consist in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.
(No Intervention)
Conventional macular damage cases treated by current protocols Intravitreal injections of anti VEGF drugs will be taken for comparison. .

Primary Outcomes

Improvement and maintenance of gain in visual acuity
time frame: Two years

Secondary Outcomes

Affordability of treatment for Colombian population
time frame: 20 years
Change in macular thickness
time frame: Two years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - • Clinical diagnosis of Macular Disease. - The patient must accept treatment with acupuncture Exclusion Criteria:

Additional Information

Official title ¿Es Util la Acupuntura en la Degeneracion Macular? Prospective Study of Efficacy of Acupuncture in Macular Diseases
Principal investigator Luz H Gutierrez, MD, MPH
Description Prospective study treating patients with several retinal macular damages with acupuncture. To join, patients required diagnosis by a specialist, confirmed with optical coherent tomography of macula. Cases are treated with acupuncture and are followed by ophthalmologist, diagnostic, Optical Coherent Tomography (OCT) revised by a retinologist that is not part of the researchers team and by Traditional Chinese Medicine. The visual outcomes were measured each two months and the time of essay is two years. The final results will be compared with those reported by medical treatment as control groups. Most of the patients have ophthalmological social security service and are examined by an independent retinologist. We will contrast the findings with them of the study. Outcomes will be measured on Visual Acuity, changes of OCT and appreciation of patients of several parameters in connection with their symptoms. The efficacy and safety of acupuncture as treatment in macular diseases is analyzed under these parameters.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Escuela Neijing.