Trial Outcomes & Findings for Efficacy of Acupuncture in Macular Diseases (NCT NCT02255981)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

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

Results posted on

2020-06-16

Participant Flow

Project was announced to ophthalmologists asking them to refer patients. Very few arrived by reference and most entered by personal interest. Study was conducted in Medical consultation site of Neijing School, in Medellín, Colombia The recruitment period was between April 2013 and May 2014.

35 patients were eligible, 2 refused to participate, 29 completed follow up. There was not an assignment, all received the same treatment although the diagnostics comprised different forms of macular damage it was pre-specified to analyze them as a single group for the Outcomes 2 eyes were excluded: 1 blind and 1 with retinal detachment.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Acupuncture & Macular Damage Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion. Periocular massage is teached and is practiced daily by the patient him or herself . Acupuncture Traditional Chinese Medicine (TCM): 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.
Overall Study STARTED	33 64
Overall Study COMPLETED	29 56
Overall Study NOT COMPLETED	4 8

Reasons for withdrawal

Reasons for withdrawal
Measure	Acupuncture & Macular Damage Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion. Periocular massage is teached and is practiced daily by the patient him or herself . Acupuncture Traditional Chinese Medicine (TCM): 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.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Efficacy of Acupuncture in Macular Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupuncture & Macular Damage n=33 Participants Intervention: Acupuncture (Traditional Chinese Medicine) and Massage: A total of 11 Chinese needles 25 x 40 were used by manual insertion. Periocular massage is teached and is practiced daily by the patient him or herself . Acupuncture Traditional Chinese Medicine (TCM): 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.
Age, Continuous	68.9 years STANDARD_DEVIATION 11.39 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

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

Population: The primary analysis includes only patients who completed the 24-month exam. The improvement in this outcome is measured on eyes which had a vision gain in lines of the Snellen chart.

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.

Outcome measures

Outcome measures
Measure	Change in VA From Baseline to the End of Study n=56 Eyes There were 13 patients with neovascular AMD in one or in both eyes. The total of eyes in this condition was 22 and the other 13 participants, had the dry form of AMD in one or both of his eyes, for a total of 23 eyes. This is not the sum of participants in each form of the disease because some of them had mixed conditions. Other 4 patients, 8 eyes, had macular dystrophy and 2 participants (3 eyes) had myopic degeneration. As the objective was not the comparison between them, it was prespecified analyze them together	VA Measured at Snellen Chart at the End of the Study VA was measured by an ophthalmologist every 2 months. The numbers below are the final VA at 24 months from the beginning.
Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study Eyes which improved VA	36 Eyes	—
Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study Eyes with stable VA	16 Eyes	—
Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study Eyes which lost VA	4 Eyes	—

PRIMARY outcome

Timeframe: 24 months from baseline.

Population: All participants received the same treatment in a treat and extend regimen with an ophthalmological review every 2 months for 2 years. Data of VA from baseline to the end of the study were compared to assess Improvement or worsening. Improved means eyes with a better score of lines, stable means equal VA and worse is a loss of lines seen.

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.

Outcome measures

Outcome measures
Measure	Change in VA From Baseline to the End of Study n=56 Eyes There were 13 patients with neovascular AMD in one or in both eyes. The total of eyes in this condition was 22 and the other 13 participants, had the dry form of AMD in one or both of his eyes, for a total of 23 eyes. This is not the sum of participants in each form of the disease because some of them had mixed conditions. Other 4 patients, 8 eyes, had macular dystrophy and 2 participants (3 eyes) had myopic degeneration. As the objective was not the comparison between them, it was prespecified analyze them together	VA Measured at Snellen Chart at the End of the Study n=56 Eyes VA was measured by an ophthalmologist every 2 months. The numbers below are the final VA at 24 months from the beginning.
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. Normal	20 Eyes	29 Eyes
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. Mild	3 Eyes	4 Eyes
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. Moderate	9 Eyes	8 Eyes
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. Severe	19 Eyes	10 Eyes
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. Blindness	5 Eyes	5 Eyes

PRIMARY outcome

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

Population: In AMD patients, some had a form in one eye and other in the fellow. "Improved" means the eyes which improved based on the number of letters gained in the ETDRS chart over the baseline and maintained for the end of the study. "Stable" if the number of letters is almost the same and "lost" if it was reduced.

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.

Outcome measures

Outcome measures
Measure	Change in VA From Baseline to the End of Study n=56 eyes There were 13 patients with neovascular AMD in one or in both eyes. The total of eyes in this condition was 22 and the other 13 participants, had the dry form of AMD in one or both of his eyes, for a total of 23 eyes. This is not the sum of participants in each form of the disease because some of them had mixed conditions. Other 4 patients, 8 eyes, had macular dystrophy and 2 participants (3 eyes) had myopic degeneration. As the objective was not the comparison between them, it was prespecified analyze them together	VA Measured at Snellen Chart at the End of the Study VA was measured by an ophthalmologist every 2 months. The numbers below are the final VA at 24 months from the beginning.
Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart Letters seen at baseline	41.5178 Letters on ETDRS scale Standard Deviation 33.7127	—
Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart Letters seen at the end of study	53.5714 Letters on ETDRS scale Standard Deviation 30.2450	—
Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart Change from baseline	14.3571 Letters on ETDRS scale Standard Deviation 18.8684	—

PRIMARY outcome

Timeframe: 2 years

Population: Patients with AMD can have both eyes with neovascular AMD or NV-AMD in one of the eyes and No NA-AMD in the fellow.

"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.)

Outcome measures

Outcome measures
Measure	Change in VA From Baseline to the End of Study n=22 eyes There were 13 patients with neovascular AMD in one or in both eyes. The total of eyes in this condition was 22 and the other 13 participants, had the dry form of AMD in one or both of his eyes, for a total of 23 eyes. This is not the sum of participants in each form of the disease because some of them had mixed conditions. Other 4 patients, 8 eyes, had macular dystrophy and 2 participants (3 eyes) had myopic degeneration. As the objective was not the comparison between them, it was prespecified analyze them together	VA Measured at Snellen Chart at the End of the Study VA was measured by an ophthalmologist every 2 months. The numbers below are the final VA at 24 months from the beginning.
Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.	13 eyes	—

SECONDARY outcome

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

Population: All the participants who had a follow up for 24 months filled a survey about their complains and limitation in daily life at the beginning, in the middle time and at the end of the study. The measure is the number of patients who reported improvement.

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.

Outcome measures

Outcome measures
Measure	Change in VA From Baseline to the End of Study n=29 Participants There were 13 patients with neovascular AMD in one or in both eyes. The total of eyes in this condition was 22 and the other 13 participants, had the dry form of AMD in one or both of his eyes, for a total of 23 eyes. This is not the sum of participants in each form of the disease because some of them had mixed conditions. Other 4 patients, 8 eyes, had macular dystrophy and 2 participants (3 eyes) had myopic degeneration. As the objective was not the comparison between them, it was prespecified analyze them together	VA Measured at Snellen Chart at the End of the Study VA was measured by an ophthalmologist every 2 months. The numbers below are the final VA at 24 months from the beginning.
Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)	61.45 percentage of participants improved	—

SECONDARY outcome

Timeframe: 2 years

Population: Participants who suffered some adverse event as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other events related or not with the therapeutic procedure.

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.

Outcome measures

Outcome measures
Measure	Change in VA From Baseline to the End of Study n=29 Participants There were 13 patients with neovascular AMD in one or in both eyes. The total of eyes in this condition was 22 and the other 13 participants, had the dry form of AMD in one or both of his eyes, for a total of 23 eyes. This is not the sum of participants in each form of the disease because some of them had mixed conditions. Other 4 patients, 8 eyes, had macular dystrophy and 2 participants (3 eyes) had myopic degeneration. As the objective was not the comparison between them, it was prespecified analyze them together	VA Measured at Snellen Chart at the End of the Study VA was measured by an ophthalmologist every 2 months. The numbers below are the final VA at 24 months from the beginning.
Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.	0 participants	—

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Researcher

Escuela Neijing

Phone: 5744211000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place