NEUROPROTECTION FOR MAINTENANCE OF VISUAL FUNCTION IN PATIENTS WITH ADVANCED PRIMARY GLAUCOMA

AIM: To evaluate the effects of a food supplement containing forskolin, homotaurine, carnosine, folic acid, vitamins B1, B2, B6 and magnesium in patients with advanced primary glaucoma already in treatment and compensated by intraocular pressure lowering drugs, during a period of 9 months.

 OBJECTIVES:

1.     To assess the effect of daily intake of homotaurine, carnosine, forskolin, vitamins B1, B2, B6, folic acid and magnesium based supplement along with topical antiglaucoma therapy on foveal sensitivity, pattern electroretinogram [PERG] amplitude in patients with advanced primary glaucoma compared with a control population only on topical therapy.

2.     To assess any further decrease of intraocular pressure in patients treated with food supplement along with topical antiglaucoma therapy compared with control patients only on topical therapy.

 **STUDY DESIGN:**Prospective, randomized, comparative, hospital based, single center interventional clinical study

STUDY LOCATION: Nethradhama Super Speciality Eye Hospital, Bengaluru, Karnataka

STUDY PERIOD: 9 Months

STUDY POPULATION: Patients diagnosed with advanced primary glaucoma already in treatment, with their intraocular pressure compensated by topical antiglaucoma drugs visiting the Glaucoma department of Nethradhama Super speciality Eye Hospital, Jayanagar, Karnataka willing to participate in the study.

 METHODOLOGY

The study will be conducted after approval by the institutional review board of Nethradhama Superspeciality Eye Hospital, Bangalore and will adhere to the tenets of declaration of Helsinki.

  Inclusion criteria:

·       Patients with a diagnosis of advanced primary glaucoma

·       IOP compensated by topical antiglaucoma medication

·       Age >18 years

·       Ability to provide written informed consent

Exclusion criteria:

·       Patients with a diagnosis of secondary glaucoma

·       Intolerance at 1 or more ingredients of the food supplement

·       Patients who are pregnant or breastfeeding

·       Patients who are involved in other trials simultaneously

Procedure: After obtaining informed consent from the patients enrolled in the study, information regarding patient’s medical history, any known allergies, type and severity of glaucoma, baseline values of pattern electroretinogram [PERG] amplitude, foveal sensitivity and IOP will be recorded. Treated patients will be given, beside their usual topical therapy, 2 tablets per day [1 in the morning and 1 in the evening] of the food supplement containing Forskolin[15 mg], Homotaurine[100 mg], L-carnosine[50 mg], vitamins B1[1.1 mg], B2[1.4 mg], B6[1.4 mg], folic acid[0.2 mg] and magnesium[150 mg]. Control patients will receive only their usual topical therapy. IOP will be measured at 3, 6 and 9 months; foveal sensitivity at 3, 9 months; pattern ERG amplitude at 6 months.

A further reduction of IOP, progressive improvement of PERG amplitude signal and foveal sensitivity suggest a neuroactive effect of the food supplement.

 STATISTICAL METHODOLOGY:

Quantitative data will be expressed as mean ± standard deviation (SD) or median (interquartile range) depending on distribution, while qualitative data will be presented as frequencies and percentages. Normality of quantitative variables will be assessed using the Kolmogorov-Smirnov test and the Shapiro-Wilk test, with the Central Limit Theorem applied for larger samples. Between group comparisons will be performed using independent t-test for normally distributed data and Mann-Whitney U tests for non-normal data. Within-group changes over time will be analyzed using paired t-tests or Wilcoxon signed-rank tests, and repeated measures will be evaluated using linear mixed-effects models. All analysis will report effect sizes, 95% confidence intervals, and a significance threshold of p-value < 0.05.