Ocular Hygiene Regimen for Cataracts and Dry Eye

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Uptown Eye Specialists

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study assesses the impact of two differing ocular hygiene regimens prior to cataract surgery. The first regimen includes an omega-3 supplement and the second without, and both include an at-home lid wipe and cleansing eye drops. These regimens will be assessed on microbial load, inflammation, tear osmolarity, and dry eye metrics. Patients will be randomized to either the omega-3 group + 3-part hygiene regimen, or the group with only the 3-part hygiene regimen. Data will be collected for inflammation through a test (InflammaDry) that measures an inflammatory marker, dry eye metrics via an imaging tool called Oculus 5M and the Canadian Dry Eye Assessment (CDEA) questionnaire, tear osmolarity through Tear Labs device, and area of growth for conjunctiva microbial load by swabbing the conjunctiva of the eye. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load swabs will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. An ocular assessment will also be completed at baseline, one week post-operation, and one month post-operation. All metrics will be compared to the fellow eye. The usage of omega-3 will be compared to the regimen without omega-3.

Research Team

Eligibility Criteria

This trial is for adults over 18 with any severity of dry eye syndrome who are undergoing cataract surgery. It's not for those unable to consent, with other eye conditions, systemic autoimmune or immune disorders, blood disorders, prior eye surgeries or treatments like ocular plugs.

Inclusion Criteria

People with any level of dry eye will be allowed to participate.

Patients 18 or older who underwent cataract surgical ocular hygiene treatment regimen prior to cataract surgery

Exclusion Criteria

You experienced any complications during your cataract surgery.

Patients with altered mental state and cannot provide informed consent

You have other eye problems like glaucoma or iritis, or you have certain medical conditions that affect your immune system or blood.

Treatment Details

Interventions

• Blephadex cleansing eyelid wipes (Other)
• Omega-3 (Dietary Supplement)
• Zocular Eyelid System Treatment (Drug)

Trial Overview The study compares two pre-cataract surgery hygiene regimens: one includes omega-3 supplements and the other does not; both use lid wipes and cleansing drops. The effects on microbial load, inflammation markers, tear osmolarity, and dry eye symptoms will be measured.

Participant Groups

Group I: Omega-3 Experimental Treatment 4 Interventions

Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.

Group II: No Omega-3 Active Control 3 Interventions

Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.

Who Is Running the Clinical Trial?

Uptown Eye Specialists

Lead Sponsor

Trials

11

Recruited

1,300+

WIlliam Osler Health Systems

Collaborator

Trials

1

Recruited

70+

Forsee Canada

Collaborator

Trials

1

Recruited

70+