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NCT Number: NCT07122635

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

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Vietnam National Eye Hospital

Hanoi, 10000, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in OSDI score

    Time frame: 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)

  2. Change in Tear film breakup time (TBUT) score

    Time frame: 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 outcomes

  1. Change in Schirmer I test value

    Time frame: 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.

  2. Change in Tear meniscus height

    Time frame: 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.

  3. Change in Corneal staining score

    Time frame: 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.

  4. Change in Conjunctival staining score

    Time frame: 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.

  5. Change in Tear film breakup pattern

    Time frame: 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.

Other outcomes

  1. Rate of side effects of diquafosol

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

    Rate of side effects of diquafosol will be assessed at each examination.

  2. Influence of Risk Factors on Treatment Effectiveness

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

    The influence of risk factors on treatment effectiveness will be evaluated (yes or no, influence or not). A Fisher's Exact Test will determine if there is a statistically significant difference (p<0.05) between subgroups of a specific risk factor.

Sponsors and collaborators

Lead sponsor

Le Xuan Cung

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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