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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Collaborator: Santen Pharmaceutical Co., Ltd.
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

1. Cataract patients who will undergo phacoemulsification procedures and intraocular lens (IOL) implants

2. Patients with dry eye disease

3. Patients are willing to participate in the study and fill out informed consent

Exclusion Criteria:

1. Subjects with lacrimal gland or eyelid disorders (ptosis, blepharospasm, lagophthalmos, entropion, ectropion, and blepharitis)

2. There are complications after cataract surgery

3. Patients with a history of using topical medications / eye drops that are used routinely

4. History of eye surgery in the last 6 months

5. Serious ocular surface disorders (Sjögren syndrome, pemphigoid, chemical trauma)

6. Using regular medication that trigger dry eye conditions (eg antihistamines, antidepressants, decongestants, anticholinergics) / allergy to diquafosol drugs