Overview

Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia

Status:
Recruiting
Trial end date:
2024-03-15
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% to prevent dry eye disease in patient who will undergo cataract surgery. The main questions it aims to answer are: - The percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery. - The differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively. - The tear osmolarity and matix metalloproteinase-9 (MMP-9) after the treatment. - The difference in visual quality improvement assessed from higher order aberrations (HOA) and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%. Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery, and will be: - Interviewed regarding their identity, history of illness, and symptoms of dry eye disease. - Examined by researchers: eye condition, contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time (TBUT) , fluorescein break up pattern (FBUP). This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Phase:
Phase 2
Details
Lead Sponsor:
Indonesia University
Collaborator:
Santen Pharmaceutical Co., Ltd.
Treatments:
Hyaluronic Acid