Clinical trial NCT04952987: Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery
Official title: Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Lead sponsor: LEC Eye Centre
Sponsor class: OTHER
Collaborators: name: Santen Oy
First posted: 2021-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Eyes with pre-existing dry eye and visually significant cataract planned for phacoemulsification
2. Patients aged18years or older and in good general health
3. 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
4. Tear break-up time (TBUT) \<10 seconds

Exclusion Criteria:

1. Eyes with complications after cataract surgery which require a prolonged course of topical medication
2. Eyes with history of contact lens wear in the previous 3 months
3. Eyes with history of regular use of topical eye drops(except artificial tears) in the previous 6 months
4. Treatment history of dry eye beyond artificial tears
5. Eyes with significant ocular surface disease (defined as CFS score of ≥3 on the Oxford scale)
6. Eyes with lacrimal or eyelid disease or ocular surface infections
7. Any ocular surgery within the prior 6 months
8. Using medications that could affect the dry eye condition (eg, antihistamines, antidepressants, decongestants, anticholinergic drugs or hormone treatment)
9. Allergies to Diquafosol

Primary outcomes:
measure: Change in Standard Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
timeFrame: 1 month preop, day of surgery, 1month and 3 months postoperatively
measure: Change in Tear Break Up Time
timeFrame: 1 month preop, day of surgery, 1month and 3 months postoperatively
measure: Change in Conjunctival and corneal fluorescein staining score
timeFrame: 1 month preop, day of surgery, 1month and 3 months postoperatively
Secondary outcomes:
measure: Change in uncorrected and best corrected visual acuity
timeFrame: 1 month preop, day of surgery, 1month and 3 months postoperatively
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: LEC Eye Centre
state: Perak
Study officials:
affiliation: LEC Eye Centre
name: Mun Wai Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: