Efficacy of Acupuncture in Macular Diseases (AMAD)
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|ClinicalTrials.gov Identifier: NCT02255981|
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : April 1, 2020
Last Update Posted : June 16, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Age-related Macular Degeneration Stargardt Disease Macular Dystrophy||Other: Acupuncture and massage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Interventional, no randomized, no masking|
|Masking:||None (Open Label)|
|Masking Description:||Masking is neither accurate nor reliable in a procedure such as acupuncture or massage.|
|Official Title:||¿Es Util la Acupuntura en la Degeneracion Macular? Prospective Study of Efficacy of Acupuncture in Macular Diseases|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Acupuncture group
Acupuncture and massage Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months
Other: Acupuncture and massage
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.
- 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 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.
- 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. [ Time Frame: 24 months from baseline. ]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.
- Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart [ Time Frame: Baseline and at end of study (up to 2 years) ]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.
- Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture. [ Time Frame: 2 years ]"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.)
- Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow) [ Time Frame: Baseline and end of study (up to 2 years) ]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.
- Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment. [ Time Frame: 2 years ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
• Clinical diagnosis of Macular Disease.
- The patient must accept treatment with acupuncture
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255981
|IPS Fundación Neijing|
|Guarne, Antioquia, Colombia, 0000|
|IPS Fundación Neijing|
|Medellin, Antioquia, Colombia, 0000|
|Principal Investigator:||Luz H Gutierrez, MD, MPH||Escuela Neijing Colombia|
|Study Director:||Jose L Padilla, MD||Hispano American Acupuncture Association-Beijing 84, Madrid, Spain|
|Study Chair:||José R Gutiérrez, MD, Opht||Sociedad Colombiana de Oftalmología|
|Study Chair:||Libia V Ferrer, Tech TCM||Escuela Neijing Colombia|
|Study Chair:||Sergio L Pineda||Escuela Neijing Colombia|
|Responsible Party:||Dra. Luz Helena Gutiérrez C, Luz Gutierrez Physician, MPH, Escuela Neijing, Research Coordinator., Escuela Neijing|
|Other Study ID Numbers:||
|First Posted:||October 3, 2014 Key Record Dates|
|Results First Posted:||April 1, 2020|
|Last Update Posted:||June 16, 2020|
|Last Verified:||June 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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|
Clinical Study Report (CSR)
|Time Frame:||Inmediate following publication and no end term.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
macular degeneration, acupuncture, OCT, Stargardt, dystrophy
Eye Diseases, Hereditary
Genetic Diseases, Inborn