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

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: Diquafosol Sodium 3%

• Registration Number: NCT07122635
• Lead Sponsor: Le Xuan Cung

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-03
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Study First Submitted: 2025-07-07
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery	Diquafosol Sodium 3%	-

Primary Outcome Measures

Name	Time	Method
Change in OSDI score	From starting diquafosol (baseline) to 12 weeks	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)
Change in Tear film breakup time (TBUT) score	From starting diquafosol (baseline) to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Schirmer I test value	From starting diquafosol (baseline) to 12 weeks	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.
Change in Tear meniscus height	From starting diquafosol (baseline) to 12 weeks	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.
Change in Corneal staining score	From starting diquafosol (baseline) to 12 weeks	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.
Change in Conjunctival staining score	From starting diquafosol (baseline) to 12 weeks	Change in conjunctival 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 conjunctival staining score, which is measured after Lissamine green staining and calculated according to NEI grading scale.
Change in Tear film breakup pattern	From starting diquafosol (baseline) to 12 weeks	Change in tear film breakup pattern from baseline (1 week after surgery) and after 12 weeks of treatment with diquafosol.; Tear film breakup pattern will be assessed after fluorescein staining.

Trial Locations

Locations (1)

Vietnam National Eye Hospital; 🇻🇳 Hanoi, Vietnam