AzTrials
AzTrials

Age-related Macular DegenerationAMADNCT02255981

Efficacy of Acupuncture in Macular Diseases

A study testing Acupuncture and massage in people with Age-related Macular Degeneration and Stargardt Disease, run by Escuela Neijing at 2 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Acupuncture and massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesColombia
Study dates
Mar 2013to Nov 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • • Clinical diagnosis of Macular Disease.
  • The patient must accept treatment with acupuncture

Who cannot join

  • None

Trial locations and contacts

2 sites in 1 country.

Colombia2 sites

  • IPS Fundación Neijing

    Guarne, Antioquia, 0000

  • IPS Fundación Neijing

    Medellín, Antioquia, 0000

Other trials in Colombia

About this study

Official title: ¿Es Util la Acupuntura en la Degeneracion Macular? Prospective Study of Efficacy of Acupuncture in Macular Diseases

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.

Read the 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.

Being tested
Acupuncture and massage
Keywords
macular degeneration, acupuncture, OCT, Stargardt, dystrophy
Medical subject headings
Macular Degeneration, Stargardt Disease, Ornithine Carbamoyltransferase Deficiency Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupuncture and massageOther

    Also called Traditional Chinese Medicine:( TCM), acupuncture chinese style

    Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.

    Periocular massage is taught and is practiced daily by the patient him or herself.

Study groups in NCT02255981
Study groupRoleWhat they receive
Acupuncture groupExperimentalAcupuncture and massage Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months .
Receives: Other: Acupuncture and massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study

    The primary objective is to assess if acupuncture treatment is linked to a change in visual acuity (VA).

    VA was obtained by an ophthalmologic assessment at baseline and every two months until month 24. VA measurements were taken with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters. The scale in Snellen is given in fractional numbers corresponding 20/20 to a normal vision at 20 ft or 6 meters. According to the World Health Organization, the normal vision is to 20/25, severe impairment corresponds to VA worse than 20/200 or legal blindness. Each fraction corresponds to a determined line of the chart in which all letters are correctly identified and the variation or gain is appreciated by the lines gained or lost by each eye.

    Improvement means a fraction better than initial, stable is no change in VA and lost is the VA worst than those of baseline.

    Measured: Baseline, 2 months and every 2 months until month 24.

  2. 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.

    Change in Visual Acuity was Measured by the Numbers of Lines seen on the Snellen Chart from baseline to the end of the trial. The measure was obtained by an ophthalmologic assessment on both eyes at the beginning of the study and every two months until month 24 using the best correction. VA measurements (lines in which all letters are correctly identified) were performed with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters and the variation is appreciated by the lines gained or lost by each eye. The measure in Snellen is given in fractional numbers. Each fraction corresponds to a determined line of the chart corresponding VA 20/20 or 6/6 to a normal vision at 20 ft or 6 meters. The range of normal vision according to the WHO is to 20/25 ft or 6/10m, Mild means VA worse than 6/12, Moderate means VA worse than 6/18, Severe means VA worse than 6/60 that is "legal blindness". Blindness is considered VA worse than 3/60.

    Measured: 24 months from baseline.

  3. Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart

    The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used. 85 letters are equivalent to 20/20 and 0 letters correspond to 20/200. It can be meaningful to analyze the results in this trial in the context of similar trials using anti-VEGF, or reporting a visual loss in those cases that are not treatable.

    Measured: Baseline and at end of study (up to 2 years)

  4. Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.

    "Improved" was defined as cases that gained in visual acuity (Note: no minimum of letters was defined). "Stable" was defined as visual acuity did not change in the sense of not losing or gaining in the final identification of the optotypes. "Lost" was defined as patients who had a worse vision at the end than at the beginning (e.g., lost visual acuity because the disease continued its course and the treatment was not effective.)

    Measured: 2 years

Secondary outcomes (2)

  1. Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)

    At study entry, major complaints of patients were collected by survey. Participants also completed a survey at the middle and at the end of the trial. This data is the percentage of participants that reported changes to the main visual complaints that they considered significant in their lives compared with the baseline.

    Measured: Baseline and end of study (up to 2 years)

  2. Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.

    To report this measure the adverse events or risks had to be observed carefully and registered in order to care for the safety and to accomplish regulations of any treatment or medical intervention. For this procedure, the usual risks are some adverse events as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other serious events related or not with the therapeutic procedure, had to be reported.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2014 (estimated)
  2. Study startMar 2013
  3. Primary completionMay 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Interventional, no randomized, no masking
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02255981
Sponsor's protocol ID
Neijing Ophthalmology
Acronym
AMAD
Status last verified
Jun 2020
First submitted
25 Sep 2014
Last updated
16 Jun 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: sex, age, ophthalmologic diagnostic data (medical examination, images) diagnostic signs on Traditional Chinese Medicine (TCM), number of sessions, visual outcome, hazards, previous treatment. Individual participant data that underlie the results reported will be shared after deidentification

Publications

  • Gutierrez L, Pineda S, Gutierrez R, Ferrer L. Acupuncture in Macular Diseases (AMAD) No published yet

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture and massage in people with Age-related Macular Degeneration and Stargardt Disease, run by Escuela Neijing at 2 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study (time frame: Baseline, 2 months and every 2 months until month 24.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02255981, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in