Efficacy of Acupuncture in Macular Diseases

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.

Time frame: 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 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.

Time frame: 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.

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.

Time frame: 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.

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.)

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.