Using Systane COMPLETE to improve dry eye symptoms before and after cataract surgery

Optimizing the Ocular Surface With Systane COMPLETE Pre- and Post-operatively in Patients With Dry Eye Planning for Cataract Surgery: An Extension Study of Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery

This study is testing if using Systane COMPLETE eye drops can help people with dry eyes feel better before and after cataract surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 20 Years to 85 Years
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06886373 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of Systane COMPLETE, a lipid-containing nano-emulsion artificial tear, on patients with dry eye undergoing cataract surgery. It compares corneal astigmatism data before and after the use of Systane COMPLETE to assess its impact on postoperative residual astigmatism. Additionally, the study measures preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT) to determine the effectiveness of the treatment in alleviating dry eye symptoms. The goal is to address the challenges posed by dry eye on surgical outcomes and patient comfort.

Who should consider this trial

Good fit: Ideal candidates include cataract patients aged 20 to 85 years who have normal cognitive function and are willing to undergo phacoemulsification and intraocular lens implantation.

Not a fit: Patients with ocular trauma, previous ocular surgery in the planned surgical eye, active ocular infections, or significant abnormalities in the ocular surface may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative discomfort and improve surgical outcomes for cataract patients with dry eye.

How similar studies have performed: While the use of artificial tears in cataract surgery is common, this specific approach with Systane COMPLETE is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria (Experimental group ): Cataract patients who participated in the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD) and did not withdraw from the trial midway.

Exclusion Criteria (Experimental group ): Patients unwilling to participate in this trial after surgery.

Inclusion Criteria(Control group):

* Cataract patients aged between 20 and 85 years.
* Patients with normal cognitive function who are able to complete the dry eye questionnaire (with - responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia.

Exclusion Criteria (Control group):

* Unable to answer the questions in the dry eye survey.
* Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
* Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.
* Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
* Using dry eye medication at screening stage.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Chiun Ho Hou, Ph.D — National Taiwan University Hospital
• Study coordinator: Chiun Ho Hou, Ph.D

Conditions: Ophthalmology, Dry eye, cataract surgery, astigmatism, nano-emulsion, artificial tears