About this trial
This pilot randomized controlled trial aims to evaluate the efficacy and safety of FSN in improving symptoms in patients with dAMD.38 eligible participants will be recruited and randomly assign them in a 1:1 ratio to the FSN group and the control group. Throughout the study, both groups will take oral vitamin C and vitamin E supplements for a total of 28 days. Participants in the FSN group will receive four treatment sessions over two weeks. Both groups will be assessed at the end of the FSN treating period during the mid-study period, with ocular blood flow dynamics measured using OCTA, followed by a two-week follow-up. The primary outcome of this trial is the change in visual acuity from baseline to week 2, with secondary outcomes including visual field, visual function scale, macular thickness, central avascular zone area vascular density, and choroidal thickness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
FSN+Vitamin supplement
Combination productFu's subcutaneous needling with oral Vitamin C and vitamin E supplements
Vitamin Supplements
Drugoral Vitamin C and vitamin E supplements
Treatment groups
Trial outcomes
Primary outcomes
Best Corrected Visual Acuity
The best corrected visual acuity at distance and near will be tested as the main outcome after 2-week treatment,which is the mid period of intervention.During vision testing, paticipants stand 5 meters from the chart with one eye covered. The chart height is adjusted so the 1.0 line aligns with their eye level. For near vision assessment, the subject positions themselves 25 cm from the vision chart with one eye occluded.
Secondary outcomes
Best Corrected Visual Acuity
Measuring vision at different time points compared with the primary outcome
Visual Function Questionnaire 25
The NEI-VFQ-25 is a 25-item version questionnaire of the NEI-VFQ (National Eye Institute Visual Functioning Questionnaire),widely applied in ophthalmic studies including cataract and macular degeneration, with established reliability and validity. The Chinese version was created through cultural adaptation and professional translation. This study employs the version provided by Zhongshan Ophthalmic Center, Sun Yat-sen University.The questionnaire comprises two subscales: visual function (12 items) and quality of life (13 items). Each item scores from 0(worst) to 100(best) , where higher scores indicate better quality of life. Different from the English original's 5/6-point scale, the Chinese version converted to 4 point scale scoring follows a reverse-calculation method: each question's score equals 4 points minus the points selected. Domain scores are summed to generate the total visual function score.
OCTA metrics
The SPECTRALIS OCT Angiography Module (Heidelberg Engineering) was utilized for fundus blood flow signal acquisition. FAZ,VD,CMT and CT will be collected as OCTA metrics of dAMD.The"FAZ Measurement" function will automatically quantify the foveal avascular zone (FAZ) area (mm²), corresponding to the superficial capillary plexus (SCP) of the macula ,and the "Density"function quantifies vessel density (VD) and automatically generates an en face projection map, providing the percentage of vascular area occupancy across the entire macula, with regional analyses of the fovea, parafovea, and temporal/superior/nasal/inferior macular sectors.The digital calipers tool within the OCT software was utilized to measure central foveal thickness (CFT) and central macular thickness (CMT).Choroid thickness (CT) will be measured vertical distance from the outer edge of the retinal pigment epithelium to the choroidal-scleral interface manually.
Visual field
The Humphrey Field Analyzer enables precise quantitative measurement of retinal light sensitivity thresholds with SITA Standard program 10-2, specifically applicable for macular field testing.Operators perform visual field examinations via touchscreen or keyboard interface at pre-treatment, post-treatment, and follow-up phases. During testing, the patient remains seated with the non-tested eye occluded, stabilizes their chin and fixates on the central target of the gaze tracking system. Each perceived light stimulus triggers a press of the handheld response button. If patients feel tired, a prolonged button press can activate a pause, allowing them to rest before resuming the measurement.
Locations
Sponsors and contacts
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Zhiming Yan
Lead sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor institution
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