Efficacy of oral Curcumin in Ocular Surface Disease of Glaucoma Patients on topical therapy

As per the available knowledge, there is a paucity of research examining the efficacy of curcumin capsules in treating OSD induced by glaucoma medications. This study aims to bridge this gap by investigating the potential benefits of curcumin, known for its anti-inflammatory and antioxidant properties, in ameliorating OSD symptoms linked to glaucoma medication usage. The proposed research intends to explore the effects of oral curcumin capsules on ocular surface health, and patient-reported outcomes in individuals experiencing OSD secondary to glaucoma medications.By identifying this gap in the literature, it aims to offer insights into novel therapeutic avenues for managing OSD specifically associated with glaucoma medication use, potentially enhancing patient comfort and treatment adherence.

The primary objective of this study is to assess the efficacy and safety of oral curcumin capsules in managing ocular surface diseases (OSD) induced by using glaucoma medications. Specifically, the study aims to:

·       a.To evaluate the impact of oral curcumin capsules on reducing OSD symptoms, including dryness, irritation, redness, and discomfort among individuals experiencing ocular surface complications because of glaucoma medications.

·       b.To investigate the effects of oral curcumin capsules on improving objective measures of ocular surface health, such as tear film stability, corneal surface changes, and epithelial integrity through clinical examinations.

Baseline examination, including best corrected visual acuity, slit lamp bio-microscopy, gonioscopy/ gonio photography, fundus examination (+90D lens), Intra-occular pressure (IOP) and applanation diurnal phasing of IOP will be recorded.Intervention:

Treatment Group/ Group 1: This group will be administered with oral curcumin capsules orally as per a predetermined dosage regimen for at least three months or till any side effects appear.

Control Group/ Group 2: This group will be receiving standard treatment for OSD caused by glaucoma medications.

Curcumin capsules will be made available in the form of Laurica K (HIS Eyeness Ophthalmic’s Pvt Ltd Co, India) soft gel capsules. Laurica K, comprising Curcuma Longa (curcumin). MCT Oil, Piperine will be administered once daily to the patients.

Follow-up Visits and Assessments

Regular follow-up visits will be conducted to monitor participants’ progress and to assess various parameters done post related to ocular health, ocular surface disease severity (OSDI scoring), and glaucoma progression in both the experimental (oral curcumin ) and control (standard treatment) groups.

Duration and Assessment Frequency:

Follow-up visits will occur initially at 4 weeks and followed by at 8 weeks and 3 months after enrolment. At each visit, comprehensive evaluations will be performed to track changes and progression in ocular parameters and glaucoma status.

Assessments Include:

Ocular Parameters:

·       For dry eyes evaluation: TBUT, Schiemer

·       Intraocular pressure measurements

·       Other relevant ocular evaluations as deemed necessary

·       Ocular Surface Analyzer (OSA)

OSDI Scoring:

The evaluation of ocular surface disease severity will be conducted by utilizing the Ocular Surface Disease Index (OSDI) questionnaire. This validated assessment tool will enable an in-depth evaluation of the impact of ocular surface disease on participants’ quality of life, providing valuable insights into the severity and effect of the condition.

Duration of Follow-up:

The follow-up period will extend over 3 months to comprehensively monitor changes in ocular health and disease progression.

Data Collection and Analysis:

The study will involve the collection and recording of data concerning changes in visual parameters, disease progression, disease severity and any adverse effects experienced by participants. In the data analysis phase, statistical methods will be employed to compare outcomes between the treatment and control groups. Additionally, within the group, a comparative analysis will be conducted to assess the parameters pre- and post-intervention.