Download Treatment of Glaucomatous Visual Fields by Novel Nutritional

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
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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
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Male or female above 50 years old
Open-angle glaucoma with balanced IOP
Severely damaged stable visual fields
Exclusion criteria:
o
o
o
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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
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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
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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.