Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Diquafosol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eyes with pre-existing dry eye and visually significant cataract planned for phacoemulsification Patients aged18years or older and in good general health Mild to moderate dry eye; non-visually significant ocular surface disease (NVS-OSD) defined as Corneal Fluorescein Staining (CFS) score of <3 on the Oxford scale Tear break-up time (TBUT) <10 seconds Exclusion Criteria: Eyes with complications after cataract surgery which require a prolonged course of topical medication Eyes with history of contact lens wear in the previous 3 months Eyes with history of regular use of topical eye drops(except artificial tears) in the previous 6 months Treatment history of dry eye beyond artificial tears Eyes with significant ocular surface disease (defined as CFS score of ≥3 on the Oxford scale) Eyes with lacrimal or eyelid disease or ocular surface infections Any ocular surgery within the prior 6 months Using medications that could affect the dry eye condition (eg, antihistamines, antidepressants, decongestants, anticholinergic drugs or hormone treatment) Allergies to Diquafosol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diquafosol|Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |