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Treatment of Glaucomatous Visual Fields by Novel Nutritional Supplement: Randomized, Double-Blind, Placebo-Controlled Study Meir Gorban, MD Future Products Management SA, Israel 1st World Congress on Controversies in Ophthalmology (COPHy) Prague, March 4-7, 2010 STUDY BACKGROUND • Glaucomatous neuropathy is known as an irreversible disease that progresses with a time by causing atrophy of the optic nerve and narrowing of the visual field. According to the recent meta-analysis, these defects are irreversible, even if the ocular pressure is controlled by medical treatment [Vass, 2007]. • Numerous studies have demonstrated the benefit of nutritional components in slowing of glaucoma progression [West, 2006]. There are, however, two major limitations in the usage of these products. First, there are no straightforward and scientificallyproven recommendations for the prevention of glaucomatous damage. Second, the available reports are mainly focused on the balancing of intraocular pressure (IOP), while it is well known that glaucoma causes significant impair of visual fields even when IOP is controlled by medications [15-25%] [Ahmed, 2006]. STUDY PURPOSE • The study purpose was to determine if the specially developed nutritional composition is effective in the treatment of glaucomatous neuropathy and whether it can potentially reverse the visual fields defects. • Investigational treatment represents novel nutritional composition of vitamins, minerals and medical herbs, specially developed for the treatment of glaucomatous neuropathy. The uniqueness of this composition is in the dosages and sequence of the selected substances that create special mutual effects, and thus, lead to the desired therapeutic effect. MATERIALS AND METHODS • • • • Design - Prospective, double-blind, placebo controlled study. Treatment - nutritional supplement or placebo in addition to the standard glaucoma therapies. Treatment period – 1 year Inclusion criteria: o o o • Male or female above 50 years old Open-angle glaucoma with balanced IOP Severely damaged stable visual fields Exclusion criteria: o o o o Other eye disease except s/p cataract Allergy to one of the components of the investigational treatment Non-stable visual fields in the last year Significant uncontrolled diseases MATERIALS AND METHODS • Primary outcome measures: o change in visual field - mean deviation [MD] o corrected pattern standard deviation [CPSD] o ocular or systemic complications. • Significant clinical (positive) response was determined as MD > 3.5 Db • Eyes with MD>-1 at baseline were considered healthy and excluded from analysis; visual fields were measured every 3 months. STUDY RESULTS • • • • • • 17 subjects (13M; 4F; mean age – 57y) completed the study: o active group: n=10; placebo group: n=7 3 from total 10 subjects [5 from total 15 eyes] in the active group demonstrated significant clinical response (Fig. 1, 3): o 30% by subject; 33% by eye Mean ΔMD improvement was significant within the active group and was about 2-fold higher as compared to placebo (Fig. 2): o Active group: - 1.9dB; 21% (p=0.04) o Placebo group: - 0.93dB; 9% (p=0.43). All subjects with significant MD improvement also showed a parallel improvement of the CPSD. No significant difference was found between the groups (p>0.05) in regards to MD and CPSD due to the small sample size. No complications were reported during the study. STUDY RESULTS Fig.1. Rate of responders per patient and per eye. [response is defined as MD improvement of ΔMD > 3.5 dB] Fig.2. Response rate (ΔMD) of all eyes [15 active and 9 placebo]. STUDY RESULTS A B C Fig.3. Group treatment: Example of VF improvement for single subject during the study period (left eye): A – start of treatment, B, C – 6, 12 months after the treatment STUDY RESULTS D E F G Fig.4. Individual treatment: Example of VF improvement for single subject treated individually (right & left eyes): D & F – start of treatment (R&L); E & G – 9 months after the treatment (R&L). DISCUSSION • Our results demonstrated significant clinical improvement in 30% of subjects, treated with the investigational supplement, which is remarkable for the “irreversible” medical condition. The similar VF improvement was already demonstrated by us for patients, treated in private practice (Fig.4) [Gorban, 2010]. • Once the similar results will be demonstrated by a larger studies, this therapeutic approach may serve as an effective and safe method for the treatment of glaucoma-damaged visual fields. As a consequence, many glaucoma patients may improve their vision and lifestyle by having complex glaucoma treatment approach by conventional drug and novel nutritional therapies.