Effectiveness of Dry Eye Treatment With Diquafosol Sodium 3% After Phaco Surgery

Le Xuan Cung60 enrolled

Overview

The goal of this observational study is to evaluate the effectiveness of diquafosol sodium 3% in patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery. The main question it aims to answer is whether using diquafosol will help improve symptoms and signs of dry eye in patients after phaco surgery.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dry Eye Disease

Interventions

Diquafosol Sodium 3%DRUG

Diquafosol Sodium 3% ophthalmic solution, 1 drop each time, 6 times daily, from baseline (1 week after the surgery) to 12 weeks

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing phacoemulsification surgery with IOL implantation * Diagnosis with grade 1, grade 2 or grade 3 dry eye one week after the surgery according to DEWS 2007 classification and Sullivan's severity grading scheme Exclusion Criteria: * Patients with grade 3 or 4 dry eye before phaco surgery * Phaco surgery with complications during or after surgery * Patients with other eye surgeries within 6 months before phaco surgery * Patients who are using other eye drops before phaco surgery, except artificial tears * Patients with acute eye infections * Patients who do not return for follow-up appointments * Patients who do not comply with treatment * Patients having allergy with diquafosol 3% * Patients having side effects with diquafosol 3% and do not want to continue using the drug

Locations (1)

Vietnam National Eye Hospital

Hanoi, Vietnam

Outcomes

Primary Outcomes

Change in OSDI score

Change in OSDI score after treatment with diquafosol from baseline (1 week after surgery) to 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, patient will be evaluated dry eye symptoms according to the OSDI questionnaire (from 0-100 points)

Time frame: From starting diquafosol (baseline) to 12 weeks

Change in Tear film breakup time (TBUT) score

Change in tear film breakup time (TBUT) score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, patient will be evaluated tear film breakup time which is measured after fluorescein staining. At each examination, TBUT score is measured 3 times to calculate the average value.

Time frame: From starting diquafosol (baseline) to 12 weeks

Secondary Outcomes

Change in Schirmer I test value

Change in Schirmer I test value after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, patient will be evaluated total tear secretion using the Schirmer I test.

Time frame: From starting diquafosol (baseline) to 12 weeks

Change in Tear meniscus height

Change in Tear meniscus height after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, tear meniscus height will be measured using TMH mode on Keratograph 5M machine.

Time frame: From starting diquafosol (baseline) to 12 weeks

Change in Corneal staining score

Change in corneal staining score after treatment with diquafosol from baseline (1 week after surgery) for 4 weeks, 8 weeks, 12 weeks. At the preoperative and postoperative examinations, patient will be evaluated corneal staining score, which is measured after fluorescein staining and calculated according to NEI grading scale.

Data from ClinicalTrials.gov

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