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| Name | Class |
|---|---|
| Santen Oy | INDUSTRY |
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The objective of this study is to evaluate the efficacy of Diquafosol 3% in the management of dry eyes before and after cataract surgery. Patients with pre-existing dry eyes and planned for cataract surgery will be started on Diquafosol eyedrops prior to surgery and treatment will be continued after cataract surgery. Eligible patients will undergo evaluation of dry eye at baseline and subsequently started on treatment with Diquafosol for the duration of 4 weeks before surgery. Further evaluations will be conducted on the day of surgery and at designated time points during and up to 12 weeks after surgery.
Title: Dry Eye Management with 3% Diquafosol Before and After Cataract Surgery
Setting: LEC Eye Centre, Ipoh, Malaysia
Background: Dry eye disease and cataract are two conditions which have been known to increase in incidence with age. Dry eye disease can also be further exacerbated by cataract surgery. Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion and is a 'first in class' therapeutic option which has been shown repeatedly to be efficacious in dry eye management.
Objective: To evaluate the efficacy of Diquafosol for dry eye management in patients with pre-existing dry eye disease before and after cataract surgery
Design: Observational case series in a private ophthalmic health facility
Study Plan: Eligible patients will have treatment with Diquas for 4 weeks prior to undergoing cataract surgery. Preoperative clinical evaluation will include documentation of severity of signs and symptoms of dry eye and this will be carried out at baseline, immediately before surgery and subsequently at Week 4 and Week 12.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diquafosol | Drug | Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Standard Patient Evaluation of Eye Dryness (SPEED) II questionnaire score | A validated dry eye questionnaire designed to evaluate eye dryness prior to cataract surgery | 1 month preop, day of surgery, 1month and 3 months postoperatively |
| Change in Tear Break Up Time | Measure of time taken for ocular tear film to disperse | 1 month preop, day of surgery, 1month and 3 months postoperatively |
| Change in Conjunctival and corneal fluorescein staining score | Fluorescein scoring system based on NEI Grading | 1 month preop, day of surgery, 1month and 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change in uncorrected and best corrected visual acuity | Uncorrected and best corrected distance and near acuity measured with the Snellen chart | 1 month preop, day of surgery, 1month and 3 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible subjects will be selected from a population of patients who have mild to moderate dry eye as well as significant cataract listed for phacoemulsification cataract surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mun Wai Lee, MD | Contact | +60179210683 | munwai_lee@lec.com.my |
| Name | Affiliation | Role |
|---|---|---|
| Mun Wai Lee, MD | LEC Eye Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEC Eye Centre | Recruiting | Ipoh | Perak | 30450 | Malaysia |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 23, 2023 | |
| Reset | Jun 7, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 23, 2023 | Jun 7, 2024 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C403315 | diquafosol |
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