Dry Eye Disease
Conditions
Keywords
Diquafosol, dry eye, phaco surgery, cataract surgery
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.
Interventions
Diquafosol Sodium 3% ophthalmic solution, 1 drop each time, 6 times daily, from baseline (1 week after the surgery) to 12 weeks
Sponsors
Le Xuan Cung
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of side effects of diquafosol | From starting diquafosol (baseline) to 12 weeks | Rate of side effects of diquafosol will be assessed at each examination. |
| Influence of Risk Factors on Treatment Effectiveness | 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. |
Countries
Vietnam
Outcome results
None listed