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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing phacoemulsification surgery and having dry eye 1 week after the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | From starting diquafosol (baseline) to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From starting diquafosol (baseline) to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of side effects of diquafosol | Rate of side effects of diquafosol will be assessed at each examination. | From starting diquafosol (baseline) to 12 weeks |
| Influence of Risk Factors on Treatment Effectiveness |
Inclusion Criteria:
Exclusion Criteria:
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Patients with grade 1, grade 2 or grade 3 dry eye according to DEWS 2007 classification and Sullivan's severity grading scheme one week after phacoemulsification surgery with IOL implantation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnam National Eye Hospital | Hanoi | 10000 | Vietnam |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 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. |
| 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. | From starting diquafosol (baseline) to 12 weeks |
| Change in Conjunctival staining score | 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. | From starting diquafosol (baseline) to 12 weeks |
| Change in Tear film breakup pattern | 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. | 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.
| From starting diquafosol (baseline) to 12 weeks |