Clinical trial NCT02255981: Efficacy of Acupuncture in Macular Diseases
Official title: ¿Es Util la Acupuntura en la Degeneracion Macular? Prospective Study of Efficacy of Acupuncture in Macular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Stargardt Disease
Macular Dystrophy
Keywords: macular degeneration, acupuncture, OCT, Stargardt, dystrophy
Lead sponsor: Escuela Neijing
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, no randomized, no masking
Primary purpose: TREATMENT

Brief 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.

Detailed description: Background.

WHO has included retinal diseases between conditions treatable by acupuncture and Traditional Chinese Medicine (TCM) has been used for retinal diseases in hospitals of China and in other parts of the world many years ago. Acupuncture and periocular massage act stimulating the vital energy to restore the normal function of the body.

Currently, most common treatments in Western Medicine, anti-VEGF, only are indicated for less than 10 percent of cases, which are the wet form or neovascular of AMD (NV-AMD) and they have restrictions for use, additionally, their cost and requirements are limiting for populations in all countries.

Objectives. The primary purpose of this study is to confirm the objective response among subjects with macular diseases treated with acupuncture and massage. The results of conventional treatment are published in similar trials and some of our patients have had intraocular injections previously.

It is important to feature the affordability of this therapy for low-income populations that do not have specialists or facilities nearby or for many governments that complain about the huge burden of the treatment of there diseases. In Colombia, the average cost of each intraocular injection by the time of this trial was about US 3.500 and it can be repeated every month, it requires a retina specialist and a surgical room, that is out of reach for many people in the country.

We did not calculate the costs of our treatment because the research team did voluntary labor, and the devices are at a very low cost, about US 0.50 in each session. Acupuncture treatment does not require special facilities as surgical rooms required in treatments with intraocular injections. The participants were not paid, they came from different economic conditions, some better, others from poorest neighborhoods or some from the rural areas.

This study includes 3 phases: Selection, Treatment, and Follow-up phases.

The selection phase included confirmed diagnosis by clinical register and OCT, Ophthalmologic assessment, and consent of the patient.

Macular diseases. In this trial, some patients had NV AMD in one or both eyes, dry AMD, myopic maculopathy or Stargardt disease. For TCM it is possible to treat all as damage of similar category.

Why no control group. There was no control group due to ethical reasons, leave the impairment without treatment in these mostly very sad persons. The second reason is the well-known difficulty to mask a procedure like acupuncture. another third reason is the possibility to contrast the results of this trial with those of similar studies conducted in eyes with conventional treatment.

In the phase of treatment, Patients received a session of acupuncture according to a standard protocol of points, and a periocular massage that was taught to the patient to be self-performed daily. The acupuncture sessions were scheduled every week initially, the evaluation of response was realized every 2 months by ophthalmologic exam and was asked to participants an optical coherence tomography (OCT) that would be realized every 6 months. Depending on the results of ophthalmologic assessment the sessions were extended gradually to every 2, 3, 5 until 13 weeks. Although tomographic assessments had been scheduled every 6 months, only a few of the participants accomplish with that due to economic limitations. Treatment continued until 24 months

All patients in the follow-up phase of this trial were monitored according to the Safety Follow-up protocol and the defined procedures and evaluations.

The final results were collected and analyzed.

Eligibility criteria: Inclusion Criteria:

* • Clinical diagnosis of Macular Disease.

  * The patient must accept treatment with acupuncture

Exclusion Criteria:

* None

Primary outcomes:
measure: Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study
timeFrame: Baseline, 2 months and every 2 months until month 24.
measure: 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.
timeFrame: 24 months from baseline.
measure: Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart
timeFrame: Baseline and at end of study (up to 2 years)
measure: Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)
timeFrame: Baseline and end of study (up to 2 years)
measure: Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.
timeFrame: 2 years
Other outcomes:
Locations:
city: Guarne
country: Colombia
facility: IPS Fundación Neijing
state: Antioquia
city: Medellin
country: Colombia
facility: IPS Fundación Neijing
state: Antioquia
Study officials:
affiliation: Escuela Neijing Colombia
name: Luz H Gutierrez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hispano American Acupuncture Association-Beijing 84, Madrid, Spain
name: Jose L Padilla, MD
role: STUDY_DIRECTOR
affiliation: Sociedad Colombiana de Oftalmología
name: José R Gutiérrez, MD, Opht
role: STUDY_CHAIR
affiliation: Escuela Neijing Colombia
name: Libia V Ferrer, Tech TCM
role: STUDY_CHAIR
affiliation: Escuela Neijing Colombia
name: Sergio L Pineda
role: STUDY_CHAIR
References:
citation: Gutierrez L, Pineda S, Gutierrez R, Ferrer L. Acupuncture in Macular Diseases (AMAD) No published yet