AN OBSERVATIONAL STUDY ON THE EFFICACY AND SAFETY FOR THE COMBINATION OF LUTEIN, VITAMIN C, ZEAXANTHIN, ZINC, COPPER, AND VITAMIN E IN INDIAN PATIENTS OF AGE-RELATED MACULAR DEGENERATION (AMD).

Abstract

Background:

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in the elderly population, particularly those over the age of 65. The progressive decline in visual function experienced by individuals with AMD significantly impacts their daily lives and incurs their social activities and independence. This study aims to conduct a post-marketing investigation of a fixed-dose combination created for patients in India affected with AMD, evaluating its safety and efficiency.

Material and Methods:

In this research, a total of 450 participants were registered in the span of 10 months. The study was conducted at Anugrah Narayan Magadh Medical College, Gaya, Bihar. During the research, efficacy and safety assessments were conducted on every visit conducted after 3 months. The efficacy assessment involved the use of two parameters, namely vision-related quality of life (VRQOL) and vision impairment score, which were obtained by the administration of a Vision Impairment Questionnaire.

Results:

Assessing the patients with the help of vision impairment and VRQOL test, the following were the observations-

For the VRQOL test, on the 2^nd and the 3^rd visit, the VRQOL increased by 19% and 33% that compared to the first assessment, this indicates a positive impact of the dosage administered. For the Vision impairment test, on visit 1 the percentage was 23% which further reduced to 15% by the second visit and 11% approx. 

Conclusion:

After the successful investigation, the combination of Vit C (250 mg), Cu (1 mg), Zn (40 mg), Lutein (5 mg), Vit E (200 IU), and Zeaxanthin (1 mg) per capsule was determined to be both effective and safe in treating age-related macular degeneration (AMD) in Indian patients.

Recommendation:

It is to consult an eye-care professional as soon as possible if vision changes and also continue to attend routine sight tests with an optometrist.