What are the effects of topical N-Acetylcarnosine [eye drops] on cataract-inhibited vision in an elderly subject? - A Case Report

Dr. Bill Misner Ph.D.

Abstract

Introduction: Cataract onset has a limited prognosis presenting a diagnostic and therapeutic challenge. Mild cataract-inhibited vision is typically managed by Doctors of Optometry with prescription eyeglasses to manage clouding of the lens or glare. If cataracts progress, surgical correction may be recommended. Case: A 72-year-old male presented with mild R>L cataract-inhibited vision requiring prescription eyeglasses. This patient was simultaneously examined in two separate eyewear clinics (by Doctors of Optometry) both before and after the patient self-administered 90-days solution N-Acetylcarnosine eye drops. At follow up, this patient's vision was so improved that both Optometrists concluded that new eyeglass prescriptions with lower lens strengths were necessary. Conclusion: The effects of N-Acetylcarnosine eye-drops in this subject may be associated with reducing the prescription-strength of his eyeglasses.

Introduction

This case report discusses changes determined by prescription eye examinations conducted by separate Doctors of Optometry following a protocol consisting of self-administered N-Acetylcarnosine eye drops to reduce cataract-inhibited vision in a male age-72y patient. Most people after age-60 increase the risk to develop mild cataracts, a clouding of the eye lens. Half the population ages 65-74, and 70% over 75 present cataract-inhibited visions. A standard eye examination uses a slit lamp machine to diagnose cataracts (1-2). The Optometrist can visually confirm that the lens of a patient’s eye appears cloudy well before the patient notices visual field loss. Cataract progression is slow at first, but later results in the patient’s consciously noticing blurred vision in an affected eye or both eyes. External factors, such as an eye injury, poor dietary habits, diabetes, smoking, medications [corticosteroids], and exposure to excess sunlight have been associated with cataract progression (2). However, if a cataract is not inhibitive or overtly bothersome, it is managed with prescription eyeglasses, the use of UV-protective eyewear outdoors, avoiding exposure to all toxic substances, and an antioxidant-rich diet (3). If a patient cannot perform normal activities: driving, reading, or looking at computer or video screens with prescription eyewear, the treatment typically recommended is a corrective surgery. Nevertheless, one researcher reported some patients treated with topical N-Acetylcarnosine (1%) eye-drops daily for 6-months demonstrated significant improvement in visual acuity (ranging from 7-100%) and glare sensitivity (ranging from 27-100%) (4). Dr. Mark Babizhayev (and colleagues) published considerable evidence demonstrating that patients’ self-administered N-Acetylcarnosine eye drops may reduce or reverse cataract-inhibited vision in patients (5-23).

Methods

The subject, a 72-year male, complained of R>L onsets of blurred vision with glare issues distorting vision. Two Optometrists determined mild onset R>L cataract formation during a routine eye exam. Visual Acuity, Ocular Motility, Refractive Error, and Binocular Slit-Lamp Examination were employed to define a corrective eyeglass prescription. Prescription reading glasses were ordered and the patient commenced using self-administered over-the-counter N-Acetylcarnosine [1%] eye drops[1] 4-times daily, 1-2 drops per eye for 90-consecutive days. After eye-drops were administered, the patient rested in a supine position for 5-10 minutes to permit complete absorption. At the end of this 90-day treatment protocol, the patient returned for follow-up eye exams to determine changes in his vision either progression or regression. The patient,[2] upon return for the 2nd eye exam, reported that his original prescription eyeglasses were too strong for optimal visual clarity.

Discussion

What is a cataract and how is it treated based on progression and severity? The American Optometric Association states: "A cataract is a cloudy or opaque area in the normally clear lens of the eye. Depending upon its size and location, it can interfere with normal vision. Most cataracts develop in persons over age 55, but they occasionally occur in infants and young children. Usually cataracts develop in both eyes, but one eye may have somewhat worse vision than the other. There is no way to prevent the development of cataracts and currently the only way to treat them is to surgically remove the natural lens in the eye. When vision has decreased to the point where the patient can no longer easily and safely perform daily activities, then cataract surgery should be considered. Cataract surgery is a procedure used to remove the natural lens in the eye when it becomes clouded, and replace it with an artificial lens in order to restore clear vision. Cataract surgery is indicated when the cataract impairs vision to the extent that it interferes with normal daily activities. Cataract extraction is one of the most frequently performed surgical procedures in the world (24)”

The initial prescription eye exams performed by two clinics’ Doctors of Optometry concluded that the formations of this patient’s cataracts were mild and surgery was not recommended. Thus, treating cataract progression by topical N-Acetylcarnosine (1%) eye-drops presented a treatment option, and if effective, it could be evaluated by follow-up eye examinations. Two separate clinics’ Doctors of Optometry performed eye examinations on this 72-year male subject both before he self-administered a 90-days topical N-Acetylcarnosine eye-drops protocol, and immediately after to determine effects (if any) on the patient’s need for prescription eyeglasses [Table I & Table II].

Conclusion

Both Doctors of Optometry 2nd eye examinations agreed that this patient had significant improvements in visual SPHERE (indicating the reduced lens power, measured in diopters, prescribed to correct farsightedness (+) ranging from 12.5-25%, and improvement in visual CYCLINDER (a plus sign for farsighted astigmatism) ranging from 16.6-25%. However, Doctor of Optometry #1 prescribed a reduced ADD (magnifying power) from 2.25-1.75, while Doctor of Optometry #2 recommended not changing in ADD (magnifying power) from the original 1.50-prescription. Both Doctors of Optometry concluded that 90-days after their initial eye examination that this 72-year male required new prescription eyeglasses indicating a 12.5-25% improvement in vision so-indicated by objective change in SPHERE and CYLINDER measures. While this case report is positive concerning one subject followed for 90-days, it may be stated that NO firm conclusion can be reached from the results of any single case study. Whether or not this self-administered N-Acetylcarnosine eye drops protocol may provide benefits for other patients with similar symptoms depends upon the individual patient. This conservative protocol, however, may be considered prior to invasive procedures pursued in patients with mild post-cataract complications.

Acknowledgements

The total costs for 8-each 2-ml containers of N-Aceytlcarnosine eye drops, 6 pairs of prescription eyeglasses, 4-each prescription eye glass examinations was funded by the author with no expectation of remuneration from Doctors of Optometry or manufacturers of N-Acetylcarnosine used in this case report.

Competing Interests

The author of this case report was the subject of this case report and presents no competing interests.

References

  1. Zigler Jr. JS, Datiles III MB. Pathogenesis of cataracts. In: Tasman W, Jaeger EA, eds. Duane's Ophthalmology. 15th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2011:chap 72B.
  2. Harding J. The epidemiology of cataract. In: Harding J, editor. Cataract biochemistry, Epidemiology and Pharmacology. Madras: Chapman and Hall; 1991. p. 83.
  3. Howes FW. Indications for lens surgery/indications for application of different lens surgery techniques. In: Yanoff M, Duker JS, eds. Ophthalmology. 3rd ed. St. Louis, Mo: Mosby Elsevier; 2008:chap 5.4.
  4. Babizhayev MA, Deyev AI, Yermakova VN, Semiletov YA, Davydova NG, Doroshenko VS, Zhukotskii AV, Goldman IM. Efficacy of N-acetylcarnosine in the treatment of cataracts. Drugs R D. 2002;3(2):87-103.
  5. Babizhayev MA, Savel'yeva EL, Moskvina SN, Yegorov YE. Telomere length is a biomarker of cumulative oxidative stress, biologic age, and an independent predictor of survival and therapeutic treatment requirement associated with smoking behavior. Am J Ther. 2011 Nov;18(6):e209-26.
  6. Babizhayev MA. Current ocular drug delivery challenges for N-acetylcarnosine: novel patented routes and modes of delivery, design for enhancement of therapeutic activity and drug delivery relationships. Recent Pat Drug Deliv Formul. 2009 Nov;3(3):229-65.
  7. Babizhayev MA, Burke L, Micans P, Richer SP. N-Acetylcarnosine sustained drug delivery eye drops to control the signs of ageless vision: glare sensitivity, cataract amelioration and quality of vision currently available treatment for the challenging 50,000-patient population. Clin Interv Aging. 2009;4:31-50.
  8. Babizhayev MA, Micans P, Guiotto A, Kasus-Jacobi A. N-acetylcarnosine lubricant eyedrops possess all-in-one universal antioxidant protective effects of L-carnosine in aqueous and lipid membrane environments, aldehyde scavenging, and transglycation activities inherent to cataracts: a clinical study of the new vision-saving drug N-acetylcarnosine eyedrop therapy in a database population of over 50,500 patients. Am J Ther. 2009 Nov-Dec;16(6):517-33.
  9. Babizhayev MA, Kasus-Jacobi A. State of the art clinical efficacy and safety evaluation of N-acetylcarnosine dipeptide ophthalmic prodrug. Principles for the delivery, self-bioactivation, molecular targets and interaction with a highly evolved histidyl-hydrazide structure in the treatment and therapeutic management of a group of sight-threatening eye diseases. Curr Clin Pharmacol. 2009 Jan;4(1):4-37.
  10. Babizhayev MA. Potentiation of intraocular absorption and drug metabolism of N-acetylcarnosine lubricant eye drops: drug interaction with sight threatening lipid peroxides in the treatment for age-related eye diseases. Drug Metabol Drug Interact. 2009;24(2-4):275-323.
  11. Babizhayev MA, Guiotto A, Kasus-Jacobi A. N-Acetylcarnosine and histidyl-hydrazide are potent agents for multitargeted ophthalmic therapy of senile cataracts and diabetic ocular complications. J Drug Target. 2009 Jan;17(1):36-63.
  12. Babizhayev MA, Minasyan H, Richer SP. Cataract halos: a driving hazard in aging populations. Implication of the Halometer DG test for assessment of intraocular light scatter. Appl Ergon. 2009 May;40(3):545-53.
  13. Babizhayev MA. Ocular drug metabolism of the bioactivating antioxidant N-acetylcarnosine for vision in ophthalmic prodrug and codrug design and delivery. Drug Dev Ind Pharm. 2008 Oct;34(10):1071-89.
  14. Guiotto A, Ruzza P, Babizhayev MA, Calderan A. Malondialdehyde scavenging and aldose-derived Schiff bases' transglycation properties of synthetic histidyl-hydrazide carnosine analogs. Bioorg Med Chem. 2007 Sep 15;15(18):6158-63.
  15. Babizhayev MA. Biological activities of the natural imidazole-containing peptidomimetics n-acetylcarnosine, carcinine and L-carnosine in ophthalmic and skin care products. Life Sci. 2006 Apr 11;78(20):2343-57.
  16. Babizhayev MA. Analysis of lipid peroxidation and electron microscopic survey of maturation stages during human cataractogenesis: pharmacokinetic assay of Can-C N-acetylcarnosine prodrug lubricant eye drops for cataract prevention. Drugs R D. 2005;6(6):345-69.
  17. Babizhayev MA, Semiletov YA, Lul'kin YA, Sakina NL, Savel'yeva EL, Alimbarova LM, Barinskii IP. 3D molecular modeling, free radical modulating and immune cells signaling activities of the novel peptidomimeticL-glutamyl-histamine: possible immunostimulating role. Peptides. 2005 Apr;26(4):551-63.
  18. Babizhayev MA, Semiletov YA, Lul'kin YA, Sakina NL, Savel'yeva EL, Alimbarova LM, Barinskii IP. Immunostimulating activities of the novel peptidomimetic L-glutamyl-histamine. Clin Exp Immunol. 2005 Mar;139(3):447-57.
  19. Babizhayev MA. Rejuvenation of visual functions in older adult drivers and drivers with cataract during a short-term administration of N-acetylcarnosine lubricant eye drops. Rejuvenation Res. 2004 Fall;7(3):186-98.
  20. Babizhayev MA, Deyev AI, Yermakova VN, Brikman IV, Bours J. Lipid peroxidation and cataracts: N-acetylcarnosine as a therapeutic tool to manage age-related cataracts in human and in canine eyes. Drugs R D. 2004;5(3):125-39.
  21. Babizhayev MA, Nikolayev GM, Goryachev SN, Bours J, Martin R. Hydration properties of the molecular chaperone alpha-crystallin in the bovine lens. Biochemistry (Mosc). 2003 Oct;68(10):1145-55.
  22. Babizhayev MA, Deyev AI, Yermakova VN, Davydova NG, Kurysheva NI, Doroshenko VS, Zhukotskii AV. Image analysis and glare sensitivity in human age-related cataracts. Clin Exp Optom. 2003 May;86(3):157-72.
  23. Babizhayev MA. Glare disability and driving safety. Ophthalmic Res. 2003 Jan-Feb;35(1):19-25.
  24. The American Optometric Association @
Table I. Initial Prescription Eye Examinations

O.D. #1

RX / SPHERE / CYLINDER / AXIS / ADD
OD / +1.50 / 2.25
OS / +0.50 / -0.90 / 090 / 2.25

O.D. #2

RX – O.D.#2 / SPHERE / CYLINDER / AXIS / ADD
OD / +1.50 / -0.75 / 090 / 1.50
OS / +0.50 / -0.50 / 095 / 1.50

Table II. Prescription Eye Examinations

[90-Days Post-Eye-Drops Protocol]

O.D. #1

RX / SPHERE / CYLINDER / AXIS / ADD
OD / +1.00 / 1.75
OS / +0.75 / -0.75 / 090 / 1.75
Difference / +0.25 / +0.15 / No Change / -0.50
Percents Vision Improved 90-days / 12.5% / 16.6% / None / 22.2%
O.D. Response / Wrote new eyeglass prescription to accommodate improved vision replacing original eyeglass prescription.

O.D.#2

RX / SPHERE / CYLINDER / AXIS / ADD
OD / +1.00 / -0.50 / 090 / 1.50
OS / +0.50 / -0.50 / 095 / 1.50
Difference / -0.50 / +0.25 / No Change / No Change
Percents Vision Improved / 25% / 25% / None / None
O.D. Response / Wrote new eyeglass prescription to accommodate improved vision replacing original eyeglass prescription.

1

[1] The eye drop products used were CAN-C by Profound Products [Sark, Great Britain] and Vision Clarity [DR Vitamins LLC, Kutztown, PA, USA].

[2] Disclosure: The patient was the author of this case report.