Efficacy of Acupuncture in Macular Diseases

NCT02255981 | Completed Results DMC

• 1 other identifier: Neijing Ophthalmology
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Age-related Macular Degeneration; Stargardt Disease; Macular Dystrophy

Keywords

macular degeneration, acupuncture, OCT, Stargardt, dystrophy

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

  24 months from baseline.

• 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.

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

• 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.)

  2 years

Secondary Outcomes (2)

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

  Baseline and end of study (up to 2 years)

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

  2 years

Study Arms (1)

Acupuncture group

EXPERIMENTAL

Acupuncture and massage Therapy of Traditional Chinese Medicine (acupuncture and Massage) for 24 months .

Other: Acupuncture and massage

Interventions

Acupuncture and massage OTHER

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.

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

Acupuncture group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Escuela Neijing: lead

Study Sites (2)

IPS Fundación Neijing

Guarne, Antioquia, 0000, Colombia

Location

IPS Fundación Neijing

Medellín, Antioquia, 0000, Colombia

Location

Related Publications (1)

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

  RESULT

MeSH Terms

Conditions

Macular Degeneration; Stargardt Disease; Ornithine Carbamoyltransferase Deficiency Disease

Interventions

Acupuncture Therapy; Massage; Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Therapy, Soft Tissue; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation; Medicine, East Asian Traditional; Medicine, Traditional

Limitations and Caveats

Participants were limited by lack of knowing and credibility of ophthalmologists in TCM OCTs every 6 months was not possible for some due to the cost. Some patients had independent evaluation and their ophthalmologist appreciated the results.

Results Point of Contact

• Title: Researcher
• Organization: Escuela Neijing

lhgut2001@gmail.com

5744211000

Study Officials

• Luz H Gutierrez, MD, MPH

  Escuela Neijing Colombia

  PRINCIPAL INVESTIGATOR

• Jose L Padilla, MD

  Hispano American Acupuncture Association-Beijing 84, Madrid, Spain

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking is neither accurate nor reliable in a procedure such as acupuncture or massage.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Luz Gutierrez Physician, MPH, Escuela Neijing, Research Coordinator.

Model Details: Interventional, no randomized, no masking

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 3, 2014
• Study Start: March 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 16, 2020
• Results First Posted: April 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Inmediate following publication and no end term.
• Access Criteria: Any

Locations

CO (2)